The Vice-President, Regulatory Affairs in partnership with the CMO and other key stakeholders will develop, operationalize and steward the Company’s global regulatory strategy and operational plans covering the full life cycle of registration and post marketing pathway for all pipeline products and commercial stage assets. The incumbent will build a high performing and collaborative regulatory team and serve as a player coach leader to advance the Company’s assets through the various regulatory stages.
- Develop regulatory strategies for individual programs including all preparatory planning for successful registration in markets assigned to the company.
- Develop and assess optimal routes to approval and lead communication and negotiation activities with applicable regulatory agencies to pave way for successful submissions for all early, clinical and commercial stage pipeline assets.
- Directly or through the RA colleagues provide strategic regulatory leadership for all pre-IND, early stage clinical development projects, and commercial products and conduct regulatory risk assessments and mitigation for all Company programs.
- Prepare briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs, and Annual reports and other documents. Respond to regulatory agencies with intelligence, diplomacy and a tone that conveys collaboration and partnership.
- Ensure that all domain/functional teams spanning the life cycle needs of each asset are appropriately informed and are appropriately structured to meet applicable domestic and international regulatory requirements in geographies of interest to the Company.
- Build productive and respectful partnerships with key stakeholders internally, from other functions within the parent-subsidiary operating environment and external partners to ensure that the Company’s strategic business imperative are met through sharing of knowledge, expertise, and relevant information.
- Provide guidance and information to the Company’s executives and R&D management on emerging trends, regulations, and health authority guidelines to ensure use of the desired regulatory strategies.
- Provide counsel, training and interpretation of FDA and other regulatory requirements to research and development teams and other appropriate personnel. Cultivate an atmosphere of transparency and problem-solving that encourages requests for advice and input by employees.
- Proactively interpret and communicate regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) in order to execute program objectives in full compliance with applicable regulations.
- Develop and maintain strong relationships with key internal and external stakeholders including regulatory officials.
- Work collaboratively with domain/functional leaders to support operational compliance to all applicable policies and standards governed by prevailing regulatory agencies.
- Represent and provide Regulatory Affairs expertise to the Company’s Promotional Review Committee regarding advertising and promotional materials.
- Work in a highly collaborative manner with cross-functional teams within affiliates and parent company.
- Perform other duties as assigned by the Company.
- MD or PhD in a scientific area and at least fifteen (15) years of progressively responsible experience in regulatory affairs within the biopharmaceutical industry, or equivalent. Must have at least ten (10) years of experience in a management role developing a high performing regulatory team.
- Experience with regulatory aspects of oncology products.
- Ability to apply knowledge of FDA, EMA, PMDA, and ICH guidelines both strategically and operationally.
- Experience leading regulatory aspects of pre-IND, early and late stage drug development through market launch and commercial phase.
- Regulatory experience with companion diagnostics a plus.
- Demonstrated experience and expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA, Scientific Advice), NDAs, and other major regulatory submissions.
- Must have extensive knowledge of the regulations, regulatory process and requirements in all major global markets.
- Ability to influence direction of complex regulatory issues; solicits information, listens well, persuades others to make important decisions and shape outcomes.
- Demonstrated grace and even temperament under pressure.
- Proven leader with a strong results orientation, positive “hands on” attitude and a sense of urgency to get things done.
- Strong analytical, written and oral communication skills.
- Ability to travel up to 20% [domestic and international].
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org