My client is a boutique professional services company focused on R&D services and solutions for the pharmaceutical, biotech, and medical device industries.  They have retained us on the newly created full-time Sr. Medical Writer position.

Job Description:

In this newly created role, you will lead and grow the R&D Medical Writing business unit. While developing high-quality clinical/regulatory medical writing deliverables in support of a clinical program. Analyze proposed plans, programs, individual studies, and related documents and deliver the required information in a compelling fashion with accuracy and consistency in the respective submission documents. 

Responsibilities:

• Lead and develop an existing Medical Writing group.
• Work with managing partners to develop business and grow revenue for the Medical Writing group.
• Build and maintain client relationships and a trusted client partnership.
• Aligning, coordinating, and building consistent messages across individual submission documents for the assigned Client’s Clinical Program:
  • Develops clinical/regulatory content, messaging, logic, and strategies within the clients defined therapeutic area to ensure effective communication in the respective submission documents (i.e. CSR, Protocol, Synopsis, etc)
  • Leads cross-functional / global client teams to develop content/messaging strategy across a program.
  • Works in close collaboration with the Client’s Therapeutic Area leads, Clinical / Safety.
  • Function, Regulatory Function, and other R&D Functions as needed.
  • Develops and drives timelines for Clinical deliverables for global submissions.
• Ensuring the Medical Writing deliverables are complete per client requirements and contract:
  • Ensuring timelines and budget requirements are met per the client contract.
  • Ensuring Client Policies, Procedures, Style Guides, etc., are adhered to.
• Responsible / contributes to the foundation of the Medical Writing Practice through:
  • Drafting internal processes / SOPs.
  • Developing/contributing to Style Guides and Templates.
  • Supporting Business Development and Marketing efforts that pertain to Medical Writing.
  • Attending Medical Writing conferences and meetings.
  • Building an external network pertaining to Medical Writing.

Qualifications:

• Relevant Science Degree Required.
• Post-graduate Science Degree (MS, PhD or MD) preferred.
• A minimum of 10 years of medical writing experience within the pharmaceutical or CRO industry.
• Demonstrated success in 3-5 years in direct management/leading teams.
• Experience in strategic management development, deployment, and execution in leading Medical Writing departments/teams.
• Ability to quickly ramp up and understand respective Therapeutic Areas.
• Ability to drive cross-functional teams.
• Business development experience.
• Solid understanding of drug development, clinical development, and program strategy.
• Solid understanding of global Submission strategy and submission lifecycles (including eCTD).
• Solid understanding of the interconnectivity of messages across individual documents within a clinical program.
• Excellent written, verbal, and presentation skills, with proficiency in the English language.
• Robust MS Office skills, specifically Word functionality (templates, tables, presentations, etc.) and Project.

#remotejobs #remoteposition #medicalwriting #lifesciences #biotech #pharmaceutical #cro #contractresearchorginization #managment #drugdevelopment #clinicaldevelopment #regulatoryaffairs #regulatoryaffairsrecruiter #regulatorysubmissions

My client is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical needs to help improve the lives of patients with serious eye disorders. With 5- approved products with a growing pipeline and 4-more in the pre-clinical stage, this is the perfect time to join this growing team.

Overview: Reporting directly to the Head of Regulatory Affairs and Quality Assurance, the Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions. In this position, you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs, IMPDs, CTAs, and original marketing applications (BLAs/MAAs), in close collaboration with our in-house CMC and Quality teams, contract manufacturing organizations, external experts, collaborators, strategic partners, and health authorities.

Responsibilities:

• Provide regulatory CMC strategic leadership to support the development of multiple innovative products.
• Write CMC technical reports as source documents and eCTD sections for INDs, and NDAs.
• Develop CMC response strategies and submissions to regulators.
• Manage the completion of CMC submission documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory guidelines, styles, and processes.
• Develop CMC briefing packages for meetings with health authorities.
• Lead the preparation for CMC meetings with health authorities.
• Shepherd proactive interactions with regulators; prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections.

Qualifications:

• Number of Years of Experience in the Function and in the Industry: Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs.
• Bachelor of Science in a scientific discipline, advanced degree highly preferred.
• Extensive experience in pharmaceutical submissions is required.
• Evidence of successful submissions to FDA and demonstrated evidence of writing regulatory documents.
• At a minimum, established working knowledge of US guidelines and regulations.
• Strong knowledge of eCTD elements and structure and regulatory technical writing skills.
• Regulatory experience supporting both development projects and commercial products.
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence greater outcomes is a plus.
• Strong knowledge of current Good Manufacturing Practices (GMP), drug development regulations, and guidelines, including ICH, and FDA guidelines.
• Proficient in the use of Electronic Data Management Systems (EDMS) and experience with Veeva Vault is strongly preferred.

#regulatorycmc #cmc #eyedisorders #opthamology #lifesciences #regulatoryaffairs #directorregulatoyaffairs #director #drugdevelopment #regulatoryaffairsrecruiter #retinaldisease #vision #newposition #cmcsubmissions

Consulting Position - Long Term 40hrs Week - Remote

Job Summary:

• Supporting the CMC Regulatory Affairs team in developing, coordinating, and implementing global CMC regulatory strategies for assigned programs and tasks.
• Provide Reg CMC support for development programs to ensure that products are developed and manufactured in compliance with appropriate regulations and guidelines.
• Translational Pharmaceutical Sciences: This innovation engine will practice rapid-cycle innovation to test and develop improvements to existing products, develop new products, and improve yield. It will combine translational research with pharmaceutical sciences and devices and will receive inputs from and into clinical research and manufacturing sciences.
• Develop global CMC Core Dossier for Module 3.
• Precision Medicine: This innovation engine will focus on developing comprehensive, value-oriented healthcare delivery packages around drug products targeted to maximize benefit and reduce risk to precise patient populations. In the process, this engine will drive innovation by practicing patient-centric R&D.

Requirements:

• B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology, or related pharmaceutical field. Minimum of 10 years’ experience in pharmaceutical product development, including significant experience in CMC regulatory affairs with a strong biologics background or equivalent.
• Experience in directing interactions with regulatory authorities desired.
• Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance.
• Significant coordination with cross-functional teams internally and regulatory authorities externally.

#contract #consulting #consultingcmc #regulatorycmc #cmc #remote #regualtoryaffairsconsulting #newpoisition #regulatoryaffairsrecruiter #lifesciences

Retained Search

Our client is an established and growing Global Medical Device/Technology company fueled by knowledge, passion, collaboration, and integrity. With operations in Australia, Europe, the US, and Aisa.  In this role, you will be responsible for developing and leading the Regulatory strategy and providing strategic and operational leadership to the organization.  The Head of Regulatory Affairs will be accountable for prioritizing the pipeline and overseeing programs through development for regulatory approval, as well as life cycle management opportunities for already approved and marketed products. This is an exciting time to join this rapidly growing organization.

Responsibilities:

• Lead global regulatory oversight and support of the global development, registration, and life-cycle management of programs.
• Responsible for oversight of the health agency meetings (FDA, EMA, TGA, MHRA, etc.) and strategic planning.
• Providing regulatory advice to the business as it impacts the commercialization strategy of the company’s products.
• Lead global oversight and support of the organization’s regulatory compliance initiatives.
• Identify and monitor current regulatory requirements the QMS must satisfy to operate legally within the jurisdictions the company targets for product release.
• Represent the company with senior customer representatives, partners, regulators, suppliers, associations, or other bodies as required.
• Engage consulting services in support of the role’s responsibilities where appropriate.
• Actively engages with industry organizations (ARM, DIA, RAPS, etc.) to drive cross-industry best practices and support evolving global regulatory guidance.
• Engage with company leadership roles such as the Global Quality Manager and GM-NPI for the establishment of efficient and effective business systems for the delivery of compliant products to customers.
• Manage all necessary engagement with Notified Bodies to support products in the market.
• Support the company’s due diligence on potential acquisitions in regulatory matters.
• Provide input to the business units and reporting to the CCSO, including via Management Review process, recommendations for improvement, and emerging regulatory compliance risk and mitigation.

Qualifications:

• B.S./B.A. in science, engineering, or related technical field is required, Regulatory Affairs Certification a plus.
• Minimum ten years’ experience in a senior regulatory affairs leadership role which encompasses a close working relationship with the FDA for medical device or combination products.
• Excellent oral communication skills and demonstrated ability to present, influence, and create solid partnerships with executive leaders and regulatory agencies and trade associations.
• Proven success in building, developing, and driving team success.
• Inspiring leader that creates energy, enthusiasm, and delivery of simultaneous high-impact projects and results.
• Previous experience in a Quality Assurance capacity with responsibility for regulatory compliance and continuous improvement initiatives in a science-based and/or technologically sophisticated manufacturing environment.
• An in-depth working understanding of Quality Management Systems, ISO 13485, and/or equivalent to support MD/IVD products (class 2 or higher preferred).
• Experience in partnering with internal and external stakeholders on key issues or submissions.
• An expert-level understanding of Compliance and Risk Management (ISO14971 preferred).
• A strong commercial acumen with an ability to apply regulatory requirements in a commercial environment.
• Ability to represent the company appropriately with senior customer representatives, partners, regulators, suppliers, associations, or other bodies as required.

#retainedsearch #medicaldevice #combinationproducts #ivd #regulatoryaffairs #newposition #fda #ema #tga #mhra #medcialdeviceregulatoryaffairs #remote #qualitymanagment #class2 #classII #commercialregulatory #regulatoryguidance #regulatoryaffairsrecruiter #globalregulatory #newposition

Retained Search

We have a newly created full-time opportunity for a Director of Regulatory Toxicology. In this role will work within the Nonclinical Safety & Development group and provide support to project teams and clients to develop and execute strategic and integrated nonclinical development programs for drugs, biologics, devices, and combination products in multiple therapeutic areas.

Organization: My client is a scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, and they are looking to expand their consultant team with an experienced scientific professional with strong interpersonal skills.

Responsibilities:

• Advise, guide, and design integrated national and international nonclinical drug development strategies for our clients.
• Provide oversight and management of program outsourcing activities.
• Review, analyze, and interpret scientific data, and effectively communicate data interpretation to project teams, clients, and regulatory agencies.
• Author and/or critically review nonclinical submission packages for scientific content and quality.
• Act as nonclinical representative for Agency interactions and meetings.
• Conduct scientific assessments (e.g., gap analysis, safety assessments).

Requirements:

• MS degree in toxicology or a related and relevant scientific field, PhD preferred.
• 15 or more years’ experience working in nonclinical development, toxicology, and/or veterinary medicine in the pharmaceutical, biotechnology, and/or contract service industries.
• Prior experience and knowledge in working with Contract Research Organizations (CRO).
• Must possess current knowledge and expertise in regulated drug development processes.
• Track record of successfully authoring quality nonclinical regulatory documents.
• Knowledgeable in regulatory guidance documents, precedents and GLP regulations.
• Excellent communication skills and ability to effectively address scientific and regulatory questions under pressure.
• Strong sense of teamwork and demonstrated experience working with project teams, clients and regulatory personnel.
• Must be detail-oriented, with an ability to think critically and innovatively.
• Must have a client service minded attitude and be able to travel (when restrictions on business travel are eased).

#regulatorytoxicologist #toxicology #toxicologist #nonclinical #cro #newposition #contractresearchorganization #remote #retained #drugdevelopment #safety #fda #newposition #lifesciences #regualtoryaffairsrecruiter

Retained Search

We have been retained for a newly created Vice President, Global Regulatory Affairs position. This role will be leading my client’s development programs focused on cancer immunotherapy.

Organization: My client is a growing immune-oncology company and leader in T-cell therapies focused on transforming the lives of cancer patients by designing and delivering cell therapies. They are breaking new ground with science and technology, making now a perfect time to join their incredibly collaborative and patient-focused team.

Role: The Vice-President, Global Regulatory Affairs provides strategic and operational leadership to support product development across the organization. In this role, you will lead interactions with global regulatory agencies, coordinate with internal senior stakeholders, and manage and direct all regulatory strategic and operational initiatives.

Responsibilities:

• Provide global regulatory leadership supporting the global development, registration, and life-cycle management of programs.
• Responsible for oversight of the health agency meetings (FDA, EMA, etc.) and strategic planning. 
• Proactively participate in the design of US and ex-US regulatory strategies for the development of cell therapy products for oncology.
• Supervise the work of all Regulatory Affairs team members, both internal, and external and manage external vendors supporting the Regulatory Affairs function.
• Actively engages with industry organizations (ARM, DIA, RAPS, etc.) to drive cross-industry best practices and support evolving global regulatory guidance.
• Oversees regulatory staff and participates in skill development, coaching, and performance feedback of regulatory staff.
• Drive adherence to regulatory requirements and guidelines.
• Participate in due diligence activities on potential licensing, acquisition, or collaboration opportunities.
• Reviews and establishes standard operating procedures (SOPs) and global regulatory affairs processes and proactively contribute to the company compliance initiatives.
• Proactively forecast and manage the budget for Regulatory Affairs.
• Represent the company at appropriate regulatory and scientific conferences.
• Perform regulatory intelligence activities – monitor regulatory changes and competitor trends/strategies.

Qualifications & Experience:

• Experience in cell and gene therapy and/or oncology.
• Bachelor’s Degree preferably in science-related discipline, Advanced Degree preferred.
• At least 15-20 years of Global Regulatory Affairs experience.
• Track record of leading regulatory activities for development program(s).
• Experience with successful marketing applications (BLAs/NDAs/MAAs).
• Proven leadership and management experience of regulatory staff.
• Experience leading regulatory interactions, including formal meetings.
• Experience working in a matrix team environment.
• Familiarity with in-vitro diagnostic device regulations.
• Well-versed in regulatory strategy and regulatory science writing.
• Extensive knowledge in ICH, FDA, EMA, and international regulations/guidelines, including those related to cell and gene therapy.
• Companion diagnostic experience (IDE, PMA) preferred.

#retainedsearch #regulatoryaffairs #oncology #celltherapy #genetherapy # immunotherapy #cart #vicepresident #remote #globalregulatoryaffairs #lifesciences #regulatoryaffairsrecruiter #in-vitrodiagnostic

Retained Search

Our client is an established and growing Global Medical Device/Technology company fueled by knowledge, passion, collaboration, and integrity. With operations in Australia, Europe, the US and Aisa.  In this role You will be responsible for developing and leading the Regulatory strategy and providing strategic an operational leadership to the organization.  The Head of Regulatory affairs will be accountable for prioritizing the pipeline, and overseeing programs through development for regulatory approval, as well as life cycle management opportunities for already approved and marketed products. This is an exciting time to join this established, growing organization.

Responsibilities:

• Lead global regulatory oversight and support of the global development, registration, and life-cycle management of programs.
• Responsible for oversight of the health agency meetings (FDA, EMA, TGA, MHRA etc.) and strategic planning.
• Providing regulatory advice to the business as it impacts the commercialization strategy of the company’s products.
• Lead global oversight and support of the organization’s regulatory compliance initiatives including:
• Identify and monitor current regulatory requirements the QMS must satisfy to operate legally within the jurisdictions company targets for product release.
• Represent company with senior customer representatives, partners, regulators, suppliers, associations, or other bodies as required.
• Engage consulting services in support of the role’s responsibilities where appropriate.
• Actively engages with industry organizations (ARM, DIA, RAPS, etc.) to drive cross-industry best practices and support evolving global regulatory guidance.
• Engage with company leadership roles such as the Global Quality Manager and GM-NPI for the establishment of efficient and effective business systems for the delivery of compliant product to customers.
• Manage all necessary engagement with Notified Bodies to support products in market.
• Support the company’s due diligence on potential acquisitions in regulatory matters.
• Provide input to the business units and reporting to the CCSO, including via Management Review process, recommendations for improvement and emerging regulatory compliance risk and mitigation.

Qualifications:

• B.S./B.A. in a science, engineering, or related technical field is required, Regulatory Affairs Certification a plus.
• Minimum 10 years’ experience in a senior regulatory affairs leadership role which encompasses a close working relationship with the FDA for medical device or combination products.
• Excellent oral communication skills and demonstrated ability to present, influence and create solid partnerships with executive leaders and regulatory agencies and trade associations.
• Proven success in building, development and driving team success.
• Inspiring leader that creates energy, enthusiasm and delivery of simultaneous high impact projects and results.
• Previous experience in a Quality Assurance capacity with responsibility for regulatory compliance and continuous improvement initiatives in a science based and/or technologically sophisticated manufacturing environment.
• An in-depth working understanding of Quality Management Systems, ISO 13485 and/or equivalent to support MD/IVD products (class 2 or higher preferred).
• Experience in partnering with internal and external stakeholders on key issues or submissions.
• An expert level understanding of Compliance and Risk Management (ISO14971 preferred).
• A strong commercial acumen with an ability to apply regulatory requirements in commercial environment.
• Ability to represent the company appropriately with senior customer representatives, partners, regulators, suppliers, associations, or other bodies as required.

#medicaldevice #quality #medicaldevicequality #retainedsearch #regulatoryaffairs #qualityassurance #leadership #qualitymanagmentsystems #qms #globaldevelopment #regulatoryaffairsrecruiter

My client is seeking a highly motivated Regulatory Affairs professional to join their growing organization. In this role, you will be responsible for supporting global regulatory submissions and ongoing regulatory compliance through the product development lifecycle. This is the perfect opportunity for a regulatory professional who is looking to take the next step in their career.

Responsibilities:

• Independently prepare global regulatory applications, including U.S. Medical submissions (Pre-Submissions, 510Ks, IDEs, and applicable supplements and annual reports), Canadian Class 2 Device License submissions, EU MDR Submissions, and other international markets.
• Participate in compliance activities, such as internal audits, FDA and Notified Body audits, complaint handling, and vendor audits.
• Assist in preparing or updating documentation and labeling as required. 
• Assist in coordinating regulatory documentation such as device listings, certificates to foreign governments, and Canadian medical device licensing.
• Prepare materials for Management Review Meetings.
• Prepare and maintain the regulatory product classifications and groupings for new products within the context of the Medical Device Directive.
• Embed with Design/Development teams to provide both technical and RA input with a view to ensuring that design documentation resultant from the design-development process can be utilized for 510(k) and Technical Files with minimal (to no) modification.
• Write technically compelling essays to submit to FDA to prove substantial equivalency

Requirements:

• BS/BA, preferably in engineering or life sciences.
• 5+ years of experience with US and EU regulatory preparations and submissions.
• Experience in Class II electro-mechanical medical devices.
• Hands-on knowledge in preparing and submitting Clinical Evaluation Reports, Medical Device Regulation submissions, 510K preparations and submittals, ongoing reporting to Medical Device regulatory agencies and knowledge of other international regulatory requirements.
• Excellent organizational, technical writing, and communication skills.
• Proficiency with Microsoft Office.
• Knowledge of ISO 13485, 21 CFR Part 820, MDSAP, and EU MDR.
• Experience drafting 510(k) documentation and EU Technical Documentation.

#medicaldevice #regulatoryaffairs #510K #classII #electromechanical #lasers #electro-mechanical #newposition #productdevelopment #fda #mdr #eu

Retained Position

We have a newly created opportunity for a Sr. Global Regulatory Lead will be the primary contact for strategic oversight on the respective therapeutic area as the subject matter expert. Responsible for leading regulatory strategic decision making that enables a project to meet its business and regulatory deliverables.

Organization: My client is an established, world-class biotherapeutics organization with operations in 35+ nations and 22,000 employees worldwide. They are driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation, and burn treatment. With a passion and commitment to delivering on their promise to save and improve lives across the globe, now is an exciting time to join this team.

Responsibilities:

• Providing innovative scientific and regulatory vision, and leadership in defining aligned global regulatory strategies for assigned products within developmental portfolio and accountable for clinical and safety content globally of regulatory documentation for these projects.
• As the primary regulatory interface within for Global Regulatory Affairs (GRA) on specific projects, the incumbent will have responsibility for ensuring collaboration with key internal stakeholders of the Core Project Team (CPT), Clinical Development Team (CDT), Safety Management Team (SMT) and Commercial Development to ensure the global regulatory strategy is an integral component of stakeholder deliverables.
• For early development projects, the Sr. GRL is a company resource for global regulatory perspective and drives the GRA perspective within the company.
• The Sr. GRL leads the Global Regulatory Affairs Strategy Team (GRAST) for assigned projects to ensure the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy.
• In partnership with GRA Regional Leads, supporting the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies.

Qualifications and Experience:

• A bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required. An advanced degree (MS/MBA, PhD or MD) is preferred.
• Minimum of 10 years’ experience in the biotech or pharmaceutical industry, with at least 8 years in Regulatory (with 5+ years of that time in a developmental stage organization).
• Experience in leading and managing Health Authority meetings.
• Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (i.e., EU, US, Japan)
• Experience working within the regulatory affairs (regional, clinical or CMC) in a global environment across two or more geographic areas (preferentially US and EU), with proven skill implementing successful global regulatory strategies.
• Experience interfacing with regulatory agencies, including leading and preparing the sponsor’s team for an interaction.
• Demonstrated experience in working with multiple stakeholders, across geographies.
• Experience working in a complex and matrix environment is required.
• Prior clinical regulatory foundation is preferred.

#retainedsearch #regulatoryaffairs #newposition #lifesciences #biotech #grl #clinicaldevelopment #drugdevelopment #director #regulatoryaffairsrecruiter #fda

Retained Search

Our client is a clinical-stage biotechnology company leveraging its immune tolerance platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. The Senior Director will be accountable for driving the development of innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs, IMPDs, CTAs, and original marketing applications (BLAs/MAAs).

Responsibilities:

• Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends.
• Excellent knowledge of ICH requirements for the Quality aspect of the development of large molecules.
• Lead early development (Pre-IND) to registration and commercialization in the US and EU and other major markets.
• Develop documents for IND and BLA submissions in eCTD format.
• Writing and reviewing CMC regulatory documents to support global filings such as IND/IMPD, BLA, MAA,v5  and equivalent.
• Writing and reviewing briefing packages for meetings with regulatory bodies (US FDA, EMA, and others)
• Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners, and CROs) to develop and execute robust CMC regulatory strategies.
• Experience in successfully leading the CMC component of meetings with major regulatory bodies such as FDA and EMA.
• Interpret GMP-related matters and review of CMC aspect of regulatory documents.
• Manages and or mentors staff members.
• Ability to significantly contribute to both developmental and commercial (marketed product) teams.

Qualifications:

• A Masters’ degree in biology, biochemical engineering, biochemistry or analytical chemistry, or related subject (Ph.D. preferred).
• 10+ years of Regulatory CMC experience with large molecules (biotechnology products) with FDA or biotechnology industry or combination.
• Experience with large molecules (therapeutic proteins produced by recombinant DNA technology).
• Extensive experience in developing documents for IND and BLA submissions in eCTD format.
• Experience also with gene therapy products is a plus.
• Experience in writing and reviewing CMC regulatory documents to support global filings such as IND/IMPD, BLA, MAA.
• Experience in the development and review of CMC regulatory documents for small molecules.
• The ability of independent thinking and decision making in collaboration with team members.
• Can do attitude and being excited about bringing new treatments to patients faster.
• Ability to interpret GMP related matters and review of CMC aspect of regulatory documents.
• Ability to independently plan, execute and manage regulatory submissions for assigned products in clinical development, during global registrations, and post-approval life cycle activities.
• Expertise in reviewing documents pertaining to due diligence for new business opportunities.
• Outstanding oral and written communication and negotiating skills.

#cmc #regulatorycmc #seniordirector #regulatoryaffairs #lifesciences #retainedsearch #biologics #bla #newposition #regulatoryaffairsrecruiter

Remote Position

Shepherd Regulatory Search has been engaged for a newly created Associate Director Global Regulatory Affairs position. In this role, you will be the point of contact for all agency interactions.

Organization: Our client is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative treatments for severe, rare muscle disorders for which there is a significant unmet medical need.

Primary Responsibilities:

• Oversees the writing, editing, reviewing, and compiling documents needed for regulatory submission activities for US and global assigned products, responsible for all areas of communication with FDA and global agencies
• Provides critical review of all documentation supporting regulatory submissions and communications
• Prepares and submits regulatory applications, annual reports/IND amendments, and meeting requests to FDA and European regulatory agencies
• Reviews and prepares responses to requests from regulatory authorities
• Provides leadership for regulatory document management systems and maintains corporate regulatory files.
• Ensures regulatory milestones are met to support regulatory submission and overall business goals of the Company,
• Contribute to the development of regulatory strategies
• Leads regulatory operations efforts for development programs by working closely with internal functional teams, external vendors, and consultants
• Oversees the external vendors and contractors with responsibility for providing regulatory support to ensure goals are achieved
• Primary liaison with regulatory agencies § Interacts with senior management to report on project or program milestones
• Provides strategic or operational input on project team
• Builds professional and effective external relationships crucial to the success of the organization
• Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders

Requirements:

• BS/BA degree in a scientific/health sciences discipline
• 7+ year’s experience in pharmaceutical Regulatory Affairs
• Experience in the preparation of submissions, regulatory documents, annual reports, amendments, and supplements
• Proven ability to strategize with team members on the optimal way of documenting various submissions and determining the preferred plan
• In-depth knowledge of overall global drug development, expertise on the timeline and process for submissions
• Expert knowledge of regulations and guidance’s affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment
• In-depth knowledge of overall global drug development
• Excellent written, interpersonal and communication skills
• Action-oriented and committed to meeting FDA and other regulations while moving projects forward
• Able to handle changing priorities and multidisciplinary tasks
• Easily gains trust and support of peers; encourages collaboration

#remote #regulatoryaffairs #newposition #associatedirector #raredisease #muslcledisorder #regulatorystrategy #lifesciences #regulatoryaffairsrecruiter #drugdevlopment #clinicaltrials ##duchenne #musculardystrophies

We have been engaged for a Director of Quality Assurance position. In this role, you will oversee and manage the overall quality organization, including design assurance, manufacturing quality, and audit compliance. The Director of Quality Assurance will ensure compliance with applicable regulations and standards and play a crucial role in ensuring safety, efficacy, and compliance.

Responsibilities:

• Oversee and manage the overall quality organization, including design assurance, manufacturing quality, and audit compliance.
• Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 820, ISO 13485, Health Canada, and European MDRs.
• Manage all aspects of the Quality Management System (QMS), including the Quality Manual and procedures/processes, such as document and data control, quality planning, training, vendor approval/monitoring, equipment maintenance and calibration, complaint handling and trending, product recalls/advisory notices, corrective and preventive action system, non-conforming materials, and incoming and final inspection.
• Manage design control activities for new and sustaining product development efforts, including risk analysis activities, such as design and process FMEA, design and process (IQ/OQ/PQ) validation/verification activities, and software validation.
• Oversee sterilization validation & biocompatibility compliance testing for single-use disposable and reusable accessories.
• Manage the clean room environment for single-use and reusable accessory processing, including certification and maintenance to international standards.
• Conduct internal and external audits of the Quality System.
• Represent the QMS internally (Authorized Management Representative) and to external customers.
• Report on the performance of the quality management system to senior management.

Requirements:

• Bachelor’s degree in a scientific, biomedical, or engineering discipline.
• 15 years of experience in Medical Device Quality Assurance, with a minimum of 5 years of hands-on management experience.
• Design Assurance experience.
• Experience with electro-mechanical medical devices.
• New product development, medical devices.
• Solid knowledge of applicable regulations, such as FDA 21 CFR Part 820 and ISO 13485, is required.
• Proven experience in building and leading technical teams.
• Solid knowledge of global regulatory requirements/standards.
• Direct experience in development and oversight of Quality Management Systems.
• Excellent interpersonal effectiveness and written/verbal listening/communication skills.
• Ability to evaluate and reorganize priorities quickly in a dynamic start-up environment.
• Excellent interpersonal skills and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.

#qualityassurance #designassurance #medicaldevice #electro-mechanical #electromechanical #imaging #laser #director #newposition #qualityauditing #iso3485 #regulatoryaffairsrecruiter

Our client has engaged us for a full-time permanent Nonclinical Consultant position. They are seeking a mid-level experienced scientific professional with a strong nonclinical study monitoring background to join their team of experienced professional toxicology consultants. Organization: A scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, and they are looking to expand their regulatory affairs consultant team with an experienced scientific professional with strong interpersonal skills.

Responsibilities:
•Manage all aspects of outsourced nonclinical studies including study design, competitive bidding, pre-study activities, study monitoring, data, and report review.
•Monitor the studies including site visits, as needed, to ensure scientific, regulatory, compliance, and animal welfare regulations expectations are met, and quality reports are delivered on an agreed-upon timeline.
•Provide technical and scientific nonclinical study advice for a wide range of study designs, routes of administration, and species commonly used in drug development.
•Provide regulatory toxicology support to clients.
•Author reports and/or regulatory documents as needed.
•Interact with clients and vendors.
•Provide scientific and innovative advice to internal and external parties.
•Participate in business development activities.

Knowledge and Skills:

•Bachelor’s degree, in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required.
•Prior experience in Study Directorship or coordination in a Contract Research Organization (CRO) is highly desired.
•A minimum of 4 years in the pharmaceutical/biotechnology industry, CRO, and/or consulting with significant study monitoring experience.
•Good understanding of technical study conduct, study design, procedures, and documentation practices and regulatory requirements.
•Proven knowledge of Good Laboratory Practices (GLP).
•Demonstrated organizational and project management skills.
•Strong computer skills (e.g. Microsoft Word, Excel, PowerPoint, etc.).
•Ability to work independently and within a group setting and to interact effectively with different functional areas.
•Excellent communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

#nonclinical #studydirector #studydesign #glp #toxicology #studyconduct #remote #regulatoryaffairsrecruiter #studymonitor

Consulting Position - Remote - Long Term

Our client is one of the world’s premier biopharmaceutical companies. With a commitment to science, medicine, research, and development focused on patients’ needs and unmet challenges. In this role, you will lead Regulatory Affairs initiatives to ensure all promotional items are prepared and executed in accordance with applicable regulations and guidelines and company policy. This is a 6-month engagement, 40 hours a week.

Job Summary:

• Oversees regulatory guidance provided by team to ensure compliance with promotional regulations.
• Responsible for Global Processes and applications of codes and regulations for Global review of products.
• Oversight/Accountable for all submissions within group.
• Approve enforcement responses.
• Manages personnel within group to ensure coverage for brand and therapeutic area responsibilities.
• Understand and interpret complex scientific issues related to regulatory requirements and promotional strategy. Able to mentor and develop skills of staff.
• Understands broad concepts within regulatory affairs and implications across organization.
• Offers creative solutions and strategies, including risk mitigation strategies.
• Develops strategy for efficient and appropriate OPDP review and play a key role in life cycle management strategy.
• Reviews competitive materials and interacts with FDA to urge enforcement activity as necessary.
• Responsible for development and training of global review processes.
• Works closely with Medical, Legal, OEC, Marketing, Marketing Operations, Sales, and Sales Training departments as well as external advertising agencies and consultants in the successful development of promotional and applicable training materials.
• Support development and maintenance of product labeling with Regulatory Affairs Labeling and Strategy groups.
• Lead for Promotion and Advertising Regulatory Review for licensing opportunities

Qualifications:

• BS/BSc preferred; BA accepted, PharmD preferred.
• 8 years industry with 6 years regulatory or related experience.
• Previous experience in Regulatory Affairs promotion and advertising; experience in managing major regulatory filing(s) e.g. Launch Advisory Materials or responses to enforcement letters.
• Prior people management experience not required but preferred.
• Extensive knowledge of applicable FDA regulations.
• Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for the development of marketing materials.
• Understands regulatory, quality, and safety systems impacting drug development and marketed product support.
• Functions independently as a decision-maker on regulatory issues.

#consulting #contract #remote #advertising #promotion #regulatoy #regulatoryaffairs #opdp #regulatoryadvertisingpromotion #newposition #regulatoryaffairsrecruiter #regulatoyreview

Regulatory Consulting Position - Long term - Remote 

The Global Regulatory Lead Consultant will be responsible for developing and directing the global regulatory strategy, objectives, policies, and programs pertaining to the development and marketing of drug and/or biological products. The GRL will be responsible for global registration and life cycle support and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.).  

Responsibilities:

• Leads the development of strategic plans and tactical implementation leading to the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs, and other relevant regulatory filings.
• Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct reports as needed.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Requirements:

• BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
• 8+ years of Regulatory experience, including equivalent experience in the biopharmaceutical industry.
• 2-5 years of management experience preferred.
• Regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as the US, EU, Japan and Canada) to ensure appropriate leadership and mentoring for regulatory staff referred experience in reviewing, authoring, or managing components of regulatory submissions.
• Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW, and post-marketing a plus.
• Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
• Strong oral and written communication, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategy/
• Must work well with global teams.

    #regulatoryaffairs #contractor #consulting #regulatoryconsulting #remote #fda #newposition #globalregualtory #regulatoryaffairsrecruiter #lifesciences #biotech #pharma #drugdevelopment