Retained Search

We have been retained on a newly created Head of Regulatory Policy & Intelligence. Reporting to the VP, Global Quality and Regulatory Affairs, the Head of Regulatory Policy will provide strong leadership and strategic direction for Regulatory strategy including the development of a global framework to facilitate and drive Regulatory as a strategic lever. As a member of the Quality and Regulatory Leadership Team, as well partnering closely with the Divisional Regulatory leaders, the Head of Regulatory Policy & Intelligence will be instrumental in facilitating all global regulatory positioning.

Organization: My client is an established and growing Medical Technology company fueled by knowledge, passion, collaboration, and integrity. As a global champion of women’s health, they are focused on improving women’s health and well-being through early detection and treatment.

Job Summary:  The Head of Regulatory Policy & Intelligence is an effective and inspiring influencer with the capability to create followership and to create transparent understanding and guidance to ensure compliance and speed of decisions such that regulatory is a facilitator for growth. Will create confidence and credibility as a trusted partner to business leaders across different functions to build a culture and community of regulatory expertise and optimization of resources and methodology across the enterprise. In conjunction with Government Affairs, identifies and recommends appropriate global regulatory intelligence and advocacy initiatives and for or against regulations through a variety of venues such as participation in external industry organizations, seminar presentations, development of white papers in alignment with business representation and training as well as, where appropriate, engages in the education and guidance to government and regulatory authorities.

Essential Duties and Responsibilities:

• Creates and delivers the strategy and framework to ensure best representation across internal and external forums/networks to achieve strategic goals. Provides impactful strategic advice and recommendations to drive commercial success. Influences internally and externally to ensure effective application and positioning within the regulatory environment to meet business needs.
• Participates in, or oversees participation in, regional committees to drive effective networking and representation to ensure a one voice policy.
• Develops and executes a regulatory intelligence strategy. Keeps abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may impact regulatory strategies and propose action plan.
• Oversees the development and implementation of appropriate systems, processes and standards.
• Establishes metrics to measure success and impact of policy and intelligence activities. Creates a dashboard for senior management on key regulatory and policy issues so that key activities are visible and can be discussed.
• Leads the development of a global regulatory policy and advocacy strategy. Works closely with internal partners and subject matter experts to plan and execute regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest. This includes to liaise closely with colleagues (R&D, Policy, etc.) leading policy activities in the external environment to ensure regulatory insights and overall alignment.
• Drives the collaboration within the company (such as Health Policy teams, Corporate Communications, etc.) to proactively understand and respond to evolving trends and ensures best position for products and access requirements regionally/globally. Creates and implements strategy with internal stakeholders to identify opportunities/threats and advocate company’s positions externally.
• Keeps Regulatory & Quality management and all internal customers, partners, and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensures issues are escalated when needed and encourage resolution at the appropriate level.

Education:         

• B.S./B.A. in a science, engineering, or related technical field is required, Regulatory Affairs Certification a plus

Experience:       

• 10+ years  progressive experience (with master’s degree) and 12+ years (with bachelor’s degree)  with at least: 5+ years working in a Medical Device environment, 5+ years of regulatory experience and 5+ years of experience working with business stakeholders within a cross-functional matrix environment

Skills:

• Advanced knowledge of global regulatory requirements related to medical devices
• Keen ability to analyze, interpret and present complex data and technical documents with ease, and eye for strategic application
• Excellent oral communication skills and demonstrated ability to present, influence and create solid partnerships with executive leaders and regulatory agencies/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
• Facilitates development of others and leads to create a followership
• Demonstrated success in navigating through uncertainty, wielding indirect influence over teams
• Drives accountability without authority and creates confidence in regulatory excellence
• Experience in negotiating with regulatory bodies on key issues or submissions

Demonstrated experience in moving regulatory intelligence discovery into action

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Shepherd Regulatory Search has been engaged for a newly created Remote Director (or) Senior 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.

Responsibilities:

• Oversees the writing, editing, reviewing, and compiling of documents needed for regulatory submission activities for US and global assigned products.
• 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 other 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.
• Research and identify new opportunities outside of assigned work that augment the Company’s mission, vision, values, and goals
• Effectively manages and mentors regulatory staff.
• Oversees assigned external vendors and contractors responsible for providing regulatory support functions to ensure goals are achieved.
• Primary liaison with regulatory agencies and interacts with senior management to report on project or program milestones.
• Provides strategic or operational input to 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.
• Fully involved and responsible for all areas of communication with FDA and other government regulatory authorities.

Experience:

• Experience in Cardiology is strongly desired.
• BS/BA degree in a scientific/health sciences discipline.
• 10+ years’ experience in pharmaceutical Regulatory Affairs.
• Experience preparing 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.
• Management 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.

#remote #remotejobs #regulatoryaffairs #cardiology #directorregulatoryaffairs #seniordirectorregulatoryaffairs #newposition #lifesciences #regulatorystrategy #drugdevelopment #clinicaltrials #FDA #regulatoryaffairsrecruiter #muscledisorder #precision medicines #duchenne #musculardystrophies

JOB SUMMARY: Maintain the quality system and support outgoing product quality through the use of engineering tools and methodologies in order to support the production, design, and development of medical devices.

Responsibilities:

• Assist in the design and development of new products by contributing to risk analysis, verification and validation test plans, etc.
• Good understanding of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA, and DOE.
• Good problem-solving experience with Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D.
• Approve Engineering Change Orders, review prints, and be familiar with Geometric Tolerancing.
• Maintain Quality Records.
• Perform Corrective Actions and Non-conformance assessments.
• Assist in investigating customer complaints.
• Perform internal audits as well as supplier audits.
• Support Incoming Inspection.
• Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems, and analysis trends.
• Participate in and lead continual improvement projects
• Support environmental and sterilization monitoring
• Some travel required for supplier support

QUALIFICATIONS:

• Bachelor’s Degree in Mechanical or Biomedical engineering or equivalent experience.
• Very good written and verbal communication skills.
• At least 5 years of engineering experience; preferably in the medical device industry.
• CQE/CQA certification helpful but not required.
• Certified biomedical auditor is preferred.
• Familiar with FDA 21CFR820, ISO13485.
• Experience with aseptic production and/or sterilization is preferred.
• Accuracy, thoroughness, attention to detail, and legibility in completing records is essential.
• Lean and 6Sigma knowledge a plus.

#qualityengineer #medicaldevice #qualityrecords #newposition #lifesciences #engineering #biomedicalengineering# sixsigma #regulatoryaffairsrecruiter

Retained Search

Our client is a growing biopharmaceutical company focused on discovering and developing precision oncology therapeutics to address existing and emerging unmet needs to improve survival and enhance the overall well-being of cancer patients.

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.

Location: Remote

Responsibilities:

• Provide global regulatory leadership supporting global development.
• Proactively participate in the design of US and ex-US regulatory strategies for the development of precision oncology therapies.
• Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.
• Form partnerships across the Science Units to provide/facilitate provisions of the appropriate regulatory affairs advice to each area.
• Prepares and coordinates regulatory submissions (ie, clinical trial applications, formal meeting documentation, submissions, etc.); supports preparations and submission of INDs and marketing applications, as applicable.
• Supports and organizes preparations for Health Authoring meetings and teleconferences.
• Ensure adherence to current regulations associated with regulatory activities.
• Guides and executes regulatory strategy for long-term development planning, including the potential to accommodate expedited development needs.
• Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of the development program (nonclinical, clinical, quality (CMC), and labeling).
• Acts as the regulatory representative on early and late phase clinical studies, ensuring regulatory compliance and guidance.
• Work within cross-functional teams to provide global regulatory expertise in support of the development, review, and approval of strategies and documents intended to enable clinical trials and marketing authorizations.
• Collaborates effectively with cross-functional teams and contract research organizations, clearly defining regulatory expectations.
• Develop and execute, or oversee global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs.
• Represent the company at appropriate regulatory and scientific conferences.

Qualifications & Experience:

• Demonstrated success in Small Molecule Oncology programs.
• Bachelor’s Degree in science-related discipline, Advanced Degree preferred.
• At least 15 years of Global Regulatory Affairs leadership experience.
• Track record of leading global regulatory activities for development program(s).
• Significant experience or equivalent of delivering positive global outcomes, across a portfolio of products, on programs varying in scientific & clinical complexity.
• Experience in precision oncology strategy is a plus.
• Extensive knowledge of ICH, FDA, EMA, HSA, PMDA, MFDS, and international regulations/guidelines.
• Must be able to solicit information, persuade others, and shape outcomes.
• Hands-on professional able to execute regulatory submissions and operations to achieve corporate goals.
• Well-versed in regulatory strategy and regulatory science writing.
• Must thrive working in a rapidly moving, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Excellent interpersonal skills and ability to develop important relationships with key stakeholders.

#remote #remotejobs #regulatoryaffairs #oncology #smallmolecule #lifesciences #globalregulatoryaffairs #regulatorystrategy #newposition #vicepresident #leadership #regulatoryaffairsrecruiter #kinase inhibitors #precisiononcology #kinase #retainedsearch

Consulting Position - Long term - Remote

This position will lead the development of a strategic integrated evidence-generation plan. Partner with GPT Evidence Generation sub-team (a multidisciplinary team), to develop/optimize the integrated strategic evidence generation initiatives across therapeutic areas, proactively anticipating any potential gaps and adjusting tactical plans to address these.

Responsibilities:

• Responsible for post-approval research excellence within the CMO.
• Supports the development of a strategy for all study types within the CMO, i.e., sponsored studies (MACs), Collaborative Research, and IIRs.
• Provides innovative thinking and scientific expertise into post-approval research programs and real-world evidence strategies.
• Supports strategic discussions for each assigned therapeutic area to identify research gaps and develop aligned strategic and tactical plans to address these gaps and works closely with GMA GPT representatives and partners responsible for executing evidence generation plan.
• Drives, builds, and maintains the strategic evidence generation plans, closely partnering with the GML, PVPA and GORE with input from multiple stakeholders (regions, SQS, etc).
• Establishes GMA framework (i.e. subteam to asset strategy team) to support evidence generation needs.
• Collaborates with cross-functional team members to define global evidentiary needs of key stakeholders (Regulatory bodies, HCPs, Patients/caregivers, Payers, and HTA bodies) to serve the evolving healthcare environment.
• Supports collaborative strategic planning and mapping of evidence-generation activities with key internal stakeholders to develop aligned and integrated generation strategies and plans.
• Provides strategic leadership and scientific direction on medical evidence activities in order to: Set standards for the utilization of medical data and maximize patients’ access to our innovative medicines.
• Participates as a functional expert on other cross-functional leadership teams.

Requirements:

• Minimum MSc degree required (preferably PhD), preferably in a health sciences-related field with 6 years of research-related experience and/or pharmaceutical industry experience.
• Experience with late-stage clinical studies, research collaborations and RWE.
• Proven track record of strong leadership, and project management and demonstrated ability to coach and mentor individuals.
• Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of stakeholders, both internal and external.
• Experience overseeing work of and mentoring other individuals with a variety of scientific and non-scientific backgrounds and training.
• Experience working in a global organization and within a matrix structure is highly desirable.

#evidencegeneration #realworldevidence #research #strategy #clinicaldevelopment #contract #remote #pharmajobs #rwe