Our client is a commercial-stage pharmaceutical company committed to developing and commercializing therapeutics to help improve patients' lives with severe eye disorders. With approved products and a robust pipeline, this is the perfect time to join this growing team.

Position: In this high visibility role, you will report directly to the Chief Regulatory Officer. The Director of Regulatory Affairs Strategy will be responsible, in alignment with the CRO, for assisting in designing regulatory strategies during the development and life-cycle management of assigned programs. In this role, you will act as the primary regulatory liaison with the US FDA and work closely with the Global Clinical Research Organization and ex-US consulting firms to coordinate the execution of established regulatory submission plans.

Responsibilities:

• Assists the Chief Regulatory Officer (CRO) in designing and implementing regulatory strategy plans for assigned products/projects, form development, and throughout the life cycle of the dossier/product.
• Working closely and collaboratively with Regulatory Operations and Regulatory CMC, this is a 'hands-on' position where an individual must be versatile and capable of managing the operational workload and strategy execution.
• Interfaces directly with the US FDA and acts as primary liaison.
• Authoring health authority responses alongside subject matter experts and submission deliverables.
• Manage the routine maintenance of open regulatory applications, emphasizing high-quality, timely submissions to Regulatory Agencies, submission activities initial IND, NDA,
• Coordinates with Regulatory Operations and Regulatory CMC.
• Works closely with CRO to prepare and facilitate informal and formal regulatory meetings aligned with established regulatory and development strategies.
• Participates actively and assists CRO in the Advertising and Promotional Review and submission (FDA 2253) process.
• Works with functional groups to ensure documents adequately support the established regulatory strategies.
• With minimal supervision, manage routine development and post-approval regulatory activities.
• Maintains working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
• Archives and maintains regulatory submissions, correspondence, and other regulatory documents in compliance with regulatory requirements and SOPs.

Qualifications:

• BA/BS degree in life sciences discipline, Master of Sciences in Regulatory Affairs is highly desirable.
• At least 5-7 years of pharmaceutical industry experience, of which at least 4 years of Regulatory Affairs strategy drug development experience.
• Experience and knowledge in preparation of INDs, NDAs, and supportive amendments or supplements.
• Working knowledge of eCTD elements and structure, ICH standards, and submission requirements.
• Experience with small molecules and drug-led-device combination products preferred.
• Ophthalmic experience preferred.
• Experience in Clinical Trial Authorization Applications in Canada, EU, and other regions/countries is preferred.
• Experience with eCTD (US and ex-US) and using Regulatory Information Management System preferred.
• Strong communication and regulatory writing skills.
• Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.

#hybrid #newjobalert #lifesciences #pharmaceutical #biotech #regulatoryaffairs #drugdevelopment #ophthalmic #executivesearch #regulatoryaffairsrecruiter

As a Senior Design Assurance Engineer for medical laser products, you will be responsible for ensuring that the products meet regulatory and quality requirements throughout the design and development process. This involves collaborating with cross-functional teams to ensure that the design outputs are verified and validated against user needs and regulatory requirements.

Responsibilities:

• Conduct product design control activities for new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
• Support Design Engineering in the creation of Design History and Technical Files.
• Interact with third-party test houses that conduct compliance testing.
• Assist the regulatory department with FDA, CE, and other regulatory submissions.
• Perform all other essential duties as assigned.

Requirements:

• Bachelor’s Degree in scientific or engineering field; electrical engineering is preferred.
• 3-5 years of experience with engineering and development of Class II electro-mechanical medical devices.​
• Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSR’s, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred.
• Hands-on experience with Programmable Electro-mechanical Medical Systems (PEMS), New Product Development (NPD), and New Product Introduction (NPI).
• Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek.
• Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power, and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred.
• Experience with lasers and optical technologies is desired but not necessary.
• Strong working knowledge of Microsoft Word and Excel.

#newposition #dessignassurance #quality #medicaldevice #medicallaser #electromechanical #iso13485 #electromechanicaldesign #regulatoryaffairsrecruiter #newproductdevelopment #lifesciences #qualityassurance #classII #npi #npd #pems

Shepherd Regulatory Search has been engaged for a newly created Remote Associate Director Regulatory Affairs position.  This role will provide regulatory expertise from preclinical through clinical development for assigned programs.

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 of 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.
• 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 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.

#remote #regulatoryaffairs #newposition #raredisease #muscledisorders #lifesciences #biotech #pharma #drugdevelopment #regulatorysubmissions #regulatoryaffairsrecruiter #clinicaldevelopment #associatedirectorregulatoryaffairs #musculardystrophy 

We have a newly created FTE opportunity for an Associate Director of Regulatory CMC. In this role, you will provide CMC Regulatory guidance and strategic support to clients and teams, ensuring that regulatory submissions and documentation are accurate and compliant with relevant regulations, guidelines, and industry standards.

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:

• Author/compile CMC sections of regulatory submissions
• Research and apply current regulatory expectations relating to manufacturing, analytical methods, stability, and supply chain controls.
• Assist in managing CMC development projects.
• Assist in the selection process for contract manufacturing/laboratory vendors to support client programs.
• Assist in the creation and execution of phase-appropriate Pharmaceutical Quality Management Systems to comply with applicable cGMPs.
• Review, assess, and/or analyze CMC development data/information to draw conclusions and/or formulate strategies to progress product development.
• Process, publish, and review electronic regulatory submissions in eCTD format.
• Perform quality control review of technical aspects of regulatory submissions and critical review of submission components to ensure technical completeness of submissions.

Requirements:

• Bachelor’s degree, preferably in a scientific field (e.g., biology, chemistry, biochemistry, etc.). An advanced degree is desirable.
• A minimum of 10 years in the pharmaceutical/biotechnology industry and consulting with at least 5 years in CMC Regulatory Affairs.
• Experience in writing and reviewing CMC regulatory documents to support global filings such as IND/IMPD, BLA, MAA.
• Good understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
• Ability to interpret GMP-related matters and review CMC aspect of regulatory documents.
• Experience with CTD format and content.
• Ability to independently plan, execute and manage regulatory submissions for assigned products in clinical development, during global registrations, and post-approval life cycle activities.
• Ability to work independently and within a group setting and to interact effectively with different functional areas.
• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• Strong computer skills using MS Word, Excel, and PowerPoint.

#cmc #regualtorycmc #lifesciences #biotech #pharma #newposition #drugdevelopment #regulatoryaffairscontracting #regulatoryaffairsconsulting #clinicaldevelopment #regulatorysubmissions #cmcsections #regulatoryaffairsrecruiter

Consulting Position - Remote

We have a newly created long-term CMC Regulatory & Quality consulting position. In this role, you will provide CMC Regulatory guidance and strategic support to clients and teams, ensuring that regulatory submissions and documentation are accurate and compliant with relevant regulations, guidelines, and industry standards.

Responsibilities:

• Author/compile CMC sections of regulatory submissions
• Research and apply current regulatory expectations relating to manufacturing, analytical methods, stability, and supply chain controls.
• Assist in managing CMC development projects.
• Assist in the preparation of study protocols/reports, specifications, analytical methods, batch records, and other technical documents supporting CMC development.
• Assist in the selection process for contract manufacturing/laboratory vendors to support client programs.
• Assist in the creation and execution of phase-appropriate Pharmaceutical Quality Management Systems to comply with applicable cGMPs.
• Review, assess, and/or analyze CMC development data/information to draw conclusions and/or formulate strategies to progress product development.
• Process, publish, and review electronic regulatory submissions in eCTD format.
• Perform quality control review of technical aspects of regulatory submissions and critical review of submission components to ensure technical completeness of submissions.
• Provide support to colleagues in the other practice areas, including clinical, nonclinical, regulatory, and quality.

Requirements:

• Bachelor’s degree, preferably in a scientific field (e.g., biology, chemistry, biochemistry, etc.). An advanced degree is desirable.
• A minimum of 5 years in the pharmaceutical/biotechnology industry and consulting with at least 3 years in CMC Regulatory Affairs.
• Good understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
• Experience with CTD format and content.
• Ability to work independently and within a group setting and to interact effectively with different functional areas.
• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• Strong computer skills using MS Word, Excel, and PowerPoint.

#remote #contractor #contracting #cmcconsultant #regulatorycmc #cmcdevelopment #qualityconsultant #lifesciences #biotech #pharma #medicaldevice #qms #qualitymanagementsystems #cgmp #gmp #regulatorysubmissions #regulatoryaffairsrecruiter #manufacturing #analyticalmethods

Organization: My client is a growing immune-oncology company and leader in T-cell therapies focused on transforming the lives of cancer patients. 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 Associate Director (or) Directory Regulatory CMC will provide CMC regulatory leadership and act as the point of contact for cross-function teams to support the strategy and development of T-cell therapies for the treatment of cancer.

Key Responsibilities:

• Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
• Acts as point of contact to cross-functional teams on regulatory CMC project issues. Ensures project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment, and communicating in a professional and timely manner.
• 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.
• Plans execute and manage regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
• Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
• Ability to remain current on CMC regulatory intelligence, including guidelines and regulatory trends, and to drive and implement strategic policy decisions.
• Evaluate change proposals for global regulatory impact and plan global amendments.

Experience:

• Bachelor’s Degree required Advanced Degree preferred.
• Minimum of 8 years of pharmaceutical/biotech experience, including 5 years of Global Regulatory Affairs (CMC) experience.
• Experience with pharmaceutical development of drug substance or product products, analytical characterization, process scale-up, and/or regulatory registration of products.
• Understanding and proven ability to provide strategic guidance to drug development, registration, and post-market support teams. Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Proven experience with filing and maintaining regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs).
• Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency interactions related to CMC submissions and product development meetings; international experience preferred.
• Knowledge of relevant domestic and global regulations and guidance.
• Ability to work effectively in cross-functional teams.
• Willing to travel domestically and internationally up to 15%.
• Experience as a Regulatory Affairs CMC product lead is strongly preferred.
• Experience in cell and gene therapy or biologics is strongly preferred.
• Experience with BLAs/NDAs/MAAs is strongly preferred.

#regulatoryaffairs #cmc #regulatorycmc #oncology #celltherapy #genetherapy # immunotherapy #cart #associatedirector #seniormanager #hybrid #remote #globalregulatoryaffairs #lifesciences #regulatoryaffairsrecruiter #t-cell #bioptech #associatedirector #director

Retained Search

Our client has retained us to fill a VP of Clinical Regulatory Position. In this hands-on role, you will lead the Clinical Development and Regulatory Affairs practice while being responsible for client engagements, leadership, and operational direction on all clinical and regulatory projects.

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 regulatory affairs consultant team with an experienced scientific professional with strong interpersonal skills.

Responsibilities:

• Develops clinical and regulatory strategies for clients.
• Provide global regulatory leadership supporting the global development, registration, and life-cycle management of programs.
• Provides strategic clinical and regulatory leadership.
• Facilitates and leads communications with agencies.
• Prepares and reviews regulatory documents for submission to FDA; oversees critical deliverables.
• Partners and collaborates with the company's senior management team to ensure strategic business goals are met by sharing knowledge and expertise.
• Responsible for oversight of the health agency meetings (FDA, EMA, etc.) and strategic planning.
• Share knowledge and provides guidance and information on emerging trends, regulations, and industry guidelines to develop accurate regulatory strategies.
• Represent the company at appropriate regulatory and scientific conferences.
• Provides counsel, training, and interpretation of FDA and other regulatory issues to staff and clients.
• Leads and mentors staff on clinical and regulatory strategies.
• Builds, leads, and manages a team of regulatory professionals by enhancing a culture where the staff is supported, growing in their capabilities, and performing to their highest level.
• Ensures clients' goals and expectations are met.

Knowledge and Skills:

• A science degree (four-year degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science is required. An advanced degree in a related field is preferred (MS, PhD or MD, DVM).
• Minimum 15 years of progressively responsible experience in regulatory affairs within the biopharmaceutical industry or equivalent.
• Minimum 10 years experience developing, leading, managing, and growing a high-performing regulatory affair team.
• 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 in leading negotiations and facilitating the resolution of issues with regulatory agencies, of interest USA FDA, with positive outcomes.
• Experience in a scientific or regulatory consulting firm is a plus.

#retainedsearch #remote #lifesciences #biotech #pharma #consulting #clinicaldevelopment #regulatoryaffairs #vicepresident #leadership #drugdevelopment #cro #cmo #regualtoryaffairsrecruiter

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
• Author/compile CMC sections of regulatory submissions
• 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.
• Develop global CMC Core Dossier for Module 3
• Review, assess, and/or analyze CMC development data/information to draw conclusions and/or formulate strategies to progress product development.•
• Process, publish, and review electronic regulatory submissions in eCTD format.•
• Perform quality control review of technical aspects of regulatory submissions and critical review of submission components to ensure technical completeness of submissions.

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.
• 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.

#remote #contracting #consulting #lifesciences #regulatorycmc #cmc #cmcregulatoryaffairs #biologics #consultant #biotech #pharma #biologics #cmccontractor #newposition #regulatoryaffairsrecruiter

Retained Search

An essential aspect of this role will be contributing to developing and mentoring a vibrant and exceptionally talented team. In this senior leadership role, you will be responsible for building and maintaining a strong relationship with current and new business opportunities while overseeing capital and technology management. Additionally, you will manage administrative, scientific, and regulatory accountability while developing and leading the overall strategy for the organization.

Organization: My client is an established consulting firm providing regulatory, scientific, and management services to the biotech and pharmaceutical industries. They have a 20-year track record of offering their clients innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Their collaborative work environment, working alongside knowledgeable consultants in multidisciplinary teams, makes this an attractive opportunity to join this growing company providing services in the business of healthcare product development.

Essential strategic and financial responsibilities include:

• Collaborates with members to help determine and implement the values, vision, and strategic goals (long and short term) of the company and executes change initiatives
• Supports the Governance function of the company
• Provide leadership and guidance to the Executive Team
• Maximizes business and operational efficiencies
• Leads and secures positive corporate culture and work-life climate
• Prioritizes clients, resources, and service provision
• Develops and implements business plans and cap X proposals

Essential operational responsibilities include:

• Provide strategic guidance to drug development on all aspects of the initial development stage to bring to market and receive approval for commercialization.
• Oversee all interactions and relationships with regulatory and health authorities and key business stakeholders
• Oversee the preparation for pre-IND, IND & NDA documentation and submissions
• Provides general oversight and management of day-to-day operations
• Provides management and leadership to direct reports
• Cultivates a work environment that facilitates recruitment, retention, and development of high-quality staff; oversees human capital decisions; ensures the development of staff
• Develops new client relationships; maintains strong client relationships and encourages the expansion of engagements; ensures the quality of client engagements; contributes expertise, where appropriate, to the provision of client services
• Oversees all contracts and the contract administration process
• Participates in professional associations and industry/trade groups
• Contributes to the corporate branding

Qualifications:

• Master’s degree in a relevant scientific discipline or equivalent based on experience
• 15 years’ experience as a scientific/regulatory consultant or relevant scientific/regulatory field
• 10 years’ experience successfully leading, managing, and developing regulatory/scientific professionals
• Discerning business leader with a successful track record in management and administration
• Possess a broad understanding of healthcare product development, the healthcare product industry, and regulation
• Demonstrated success in client development and retention, as well as providing product and business development support to clients
• Excellent leadership, collaborative management practices, executive communication, and interpersonal skills; strong attention to detail and organizational skills

#retainedsearch #lifesciences #regulatoryaffairs #buisnessdevelopment #leadership #ceo #regulatorysubmissions #managment #newposition #biothech #pharma #regulatoryaffairsrecruiter

As a Senior Design Assurance Engineer for medical laser products, you will be responsible for ensuring that the products meet regulatory and quality requirements throughout the design and development process. This involves collaborating with cross-functional teams to ensure that the design outputs are verified and validated against user needs and regulatory requirements.

Responsibilities:

• Conduct product design control activities for new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
• Support Design Engineering in the creation of Design History and Technical Files.
• Interact with third-party test houses that conduct compliance testing of IPG products.
• Assist the regulatory department with FDA, CE, and other regulatory submissions.
• Perform all other essential duties as assigned.

Requirements:

• Bachelor's Degree in scientific or engineering field; electrical engineering is preferred.
• 3-5 years of experience with engineering and development of Class II electro-mechanical medical devices.​
• Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred.
• Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek.
• Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred.
• Experience with lasers and optical technologies desired but not necessary.
• Strong working knowledge of Microsoft Word and Excel.

#newposition #dessignassurance #quality #medicaldevice #medicallaser #electromechanical #iso13485 #electromechanicaldesign #regulatoryaffairsrecruiter

Retained Search

Shepherd Regulatory has been retained for a newly created remote US Regulatory Affairs Lead, Oncology position. This position will be accountable for developing and maintaining the US regulatory strategy documents and advising on US regulatory issues. Our client is committed to the development and commercialization of innovative oncology therapies.

Position Overview: The Regulatory Affairs Lead is responsible for proactively developing innovative and robust US Regulatory Affairs Strategies for assigned products and lifecycle assets in the oncology portfolio. In this role, you will serve as the liaison to the FDA for assigned oncology projects in clinical development. This position will lead the strategic development of documentation submitted to the FDA and lead FDA meetings and negotiations.

Key Responsibilities:

• Responsible for regulatory strategy supporting product development plans, clinical trials and new drug applications, and product life cycle management.
• Act as a strategic thinker with a "think out of the box" mindset equipped with an ability to facilitate complex decision-making and a willingness to defend difficult positions.
• Keep up with the current knowledge and understanding of complex medical and scientific subject matter and evolving US regulatory changing landscape.
• Demonstrated experience with authoring and preparing regulatory submissions, including NDA, MAA, INDs, Health Authority meeting briefing documents, and proven success in all types of formal meetings with the US FDA, including the Oncology Division.
• Prepare strategy and development of filings achieving award in expedited status including but not limited to accelerated approval, breakthrough designation, fast track, and priority review.
• Experienced in confirmatory trial in strategy development and mitigating risks/ challenges.
• Focus on clinical, and regulatory affairs filings and provide strategic and operational leadership on the project teams based on a thorough understanding of the development of drug products.

Requirements:

• B.A./B.S. or higher degree (s) in the sciences, or health-related field, minimum 8 years regulatory strategy experience.
• At least 5 years' experience in drug development with recent 3 years in Oncology.
• Solid working knowledge of drug development process and US regulatory requirements.
• Demonstrated success in developing and implementing regulatory strategies for US INDs, BLA, and NDAs throughout all phases of drug development, primarily through late-phase challenges.
• Must have experience in authoring/ preparing regulatory submissions, including meeting documents for all types of formal meetings with the FDA, INDs, NDAs/ BLAs, and key supplements.
• Must have experience in direct interaction/negotiation experience with US FDA in formal meetings.
• Demonstrated experience successfully guiding the clinical team through a complicated and ever-changing regulatory landscape.
• Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
• Excellent personal and intercultural skills paired with the ability to work cross-functionally
• Experience in electronic document management systems and e-filing to the FDA portal.

#retainedsearch #newposition #remoteposition #oncology #regulatoryaffairsstrategy #drugdevelopment #clinicaldevelopment #lifesciences #biotech #fda #oncologydivision #oncologyportfolio #regulatoryaffairsrecruiter

Consulting Position - Long Term 40hrs Week - Remote

The Global Regulatory Lead Consultant is responsible for developing and directing the global regulatory strategy, objectives, policies, and programs for developing and marketing 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 preferred 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 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 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 strategies.
• Must work well with others and within global teams.

#contractposition #consulting #regulatoryconsulting #regulatoryaffairs #biologics #lifesciences #remoteposition #biopharmaceutical #biotech #globalregulatoryaffairs #regulatorystrategy #drugdevelopment #clinicaldevelopment #regulatorysumbissions #regualtoryaffairsrecruiter #healthauthority #fda

We have a newly created remote opportunity for a Quality Assurance/GMP/CMC Subject Matter Expert. In this role, you will establish and manage phase-appropriate Quality Management Systems to support client development activities and maintain compliance with regulatory expectations.

Organization: My client is a partially employee-owned (ESOP) 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:

• Lead Quality Assurance oversight of client-outsourced CMC development programs, including interfacing with vendors (CMOs, etc.), review/approval of GMP documentation, lot dispositioning, maintenance of CMC documents, etc. 
• Draft and negotiate Quality Agreements with client vendors and suppliers.
• Oversee GMP vendor qualification, including the design and use of questionnaires and the execution of GMP site audits.
• Review and maintain controlled documentation to ensure compliance with specifications, master and executed batch records, test methods, protocols, and reports. 
• Lead investigations, release batches and assign lot dispositions.
• Develop and maintain stage-appropriate quality management systems for clients to meet all regulatory requirements for development and commercial activities.
• Author and review Standard Operating Procedures.
• Interact efficiently with managers and other functional groups to identify issues.

Requirements & Experience:

• Bachelor's degree in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required.
• A minimum of 10-15 years in the pharmaceutical/biotechnology industry and/or consulting with at least 6 years in Quality Assurance relating specifically to the oversight of CMC development.
• Consulting experience and RQAP certification are preferred.
• Experience in outsourced development program quality oversight and auditing.
• Excellent understanding and stage-appropriate application of GMP regulations and ICH and FDA CMC and Quality guidance documents.
• 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.
• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

#remoteposition #qualityassurance #quality #sme #cmc #regulatorycmc #gmpregulations #qualityquidance #lifesciences #regulatoryaffairsconsulting #contractors #cro #qms #qualitymanagmentsystems #regualtoryaffairsrecruiter #biotech #medicaldevice #cmo

Retained Search

Our client has retained us for a newly created Remote Executive Director, Global Regulatory Affairs position. In this hands-on role, you will develop and deliver innovative global regulatory strategies for product development and approval. The Executive Director of Global Regulatory Affairs will provide strategic direction and guidance on regulatory requirements for assigned gene therapy development programs, driving premarket strategies that lead to robust submissions and timely product approvals.

Position Responsibilities:

• Drive global regulatory affairs strategies and activities across assigned programs.
• Partner closely with cross-functional colleagues to articulate and translate nonclinical and clinical regulatory requirements into practical, strategic regulatory strategies and plans.
• Identify and assess regulatory risks & define strategies to mitigate such risks.
• Plan, write, and review drug applications and submissions, as well as represent Regulatory Affairs with various internal departments to manage activities and coordinate the preparation of regulatory submissions.
• Prepare for and support meetings with regulatory bodies.
• Build and maintain excellent relationships with relevant regulatory agencies.
• Monitor the impact of changing regulations on submission strategies.
• Serve as regulatory subject matter expert throughout the product lifecycle.

Minimum Requirements/Qualifications:

• 15+ years of pharmaceutical/biotechnology industry experience in Regulatory Affairs.
• University degree in life sciences required; advanced degree(s) preferred.
• Experience with rare disease therapeutic products and experience with cell and gene therapy products is highly desirable.
• Experience as lead regulatory representative for development programs required, with sufficient gravitas to lead the development team through regulatory processes.
• Experience and comfort with a fast-paced small biotech company environment.
• Knowledge and experience in interpretation of regulations, guidelines, policy statements, etc.
• Experience in preparing major regulatory submissions and supportive amendments or supplements for early and late-stage development programs.
• Demonstrate excellent leadership and communication skills.
• Demonstrate strong organizatinal and interpersonal skills.

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Retained Search

Our client has retained us for a newly created Senior Regulatory and Quality Affairs Subject Matter Expert Position.  In this role, you will support the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services in Washington, DC.  The Senior Regulatory Affairs SME will be an integral part of the BARDA mission to support the advanced development and procurement of drugs, vaccines, and other products considered national health security priorities.  This position will serve as Regulatory Affairs and Quality Affairs subject matter expert for multiple BARDA programs and projects involving developing and manufacturing vaccine medical countermeasures specific to pandemic influenza.

Specific duties may include but are not limited to:

• Provide scientific/regulatory affairs/quality support, advice, and guidance for assigned programs and projects, including emerging infectious diseases.
• Monitor 21CFR compliance on assigned programs and projects.
• Support BARDA in the review of contractor submissions of Regulatory strategy and documents, including development plans, study reports, study protocols, and reports.
• Support BARDA in reviewing contractor submissions, including INDs, Briefing Documents, Orphan Drug Applications, Marketing Applications, etc.
• Assist in preparation for and participate in Regulatory Affairs meetings with FDA, as assigned.
• Monitor BARDA-supported contractors’ project timelines for critical Regulatory and Quality performance measures, and provide recommendations to overcome challenges and reduce program risk.
• Participate in site visits/audits to review and monitor vendor progress toward completion of contract milestones.
• Assist Project Team and BARDA-supported contractors to develop and manage strategy, protocols, and FDA applications for Emergency Use Authorizations.
• Participate or act as the Regulatory Affairs representative on various cross-functional teams as assigned.
• Maintain current knowledge of the U.S. competitive landscape, Regulatory environment, regulations, and guidance.
• Provide Regulatory opinions on specific issues.
• Support contract initiation/negotiation efforts by providing Regulatory and Quality assessments of white papers and proposals to BARDA.
• Provide Regulatory advice and counsel on draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and support technical and cost evaluation for white papers/proposals.
• Draft meeting minutes, trip reports, and technical assessments and recommendations (including Regulatory opinions) on the Regulatory aspects of BARDA-contractor interactions.

Desired Experience:

• M.S. or higher in life sciences or a related field is highly preferred.
• Minimum 15 years of drug or biologics development; Pharmaceutical industry experience in Regulatory Affairs and/or Quality affairs at the Director, VP, or Sr. Management levels.
• Experienced in addressing FDA/CBER hurdles (especially during late-stage product development).
• Experience in identifying and resolving Quality, Regulatory Affairs, clinical, or process development problems for seasonal or pandemic influenza vaccines.
• Experience with and understanding of influenza risk management, including seasonal influenza and potential pandemic risk posed by influenza A viruses that circulate in animals but not humans.
• Excellent people and communication skills, with a team-oriented leadership style.

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