Director, Regulatory Affairs
Redwood City , CA /
Regulatory Affairs /
Full Time Employee (FTE)
The Director of Regulatory Affairs responsibilities include high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions. Provide direction for effective execution of the developed regulatory strategies, tactics and implementation of all regulatory aspects of assigned program, and responsible for the timely development and submission of regulatory documentation. Provide guidance on content and provide review and approval of regulatory submissions including requests for Designation, Meeting Background Packages, INDs and CTAs. Build partnerships within a matrixed team-oriented structure with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resource(s). Work in collaboration with the Regulatory Strategic Advisor, to inform/advise program requirements and timelines. Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedence.
- Provide regulatory guidance throughout the development process.
- Prepare clear and effective regulatory submissions on behalf of company leveraging internal and external resources.
- Prepare and lead meetings with regulatory bodies to include but not limited to Pre-IND meetings, Type C meetings, EOP II meetings, pre-NDA meetings, and EU Scientific Advice
- Be primary contact with regulatory bodies in US and Internationally, while building and maintaining strong relationships.
- Review, analyze and translate regulatory requirements into a workable deliverable for project meetings, senior and executive management decisions.
- Supervise, interact with and/or coordinate with contract regulatory staff and external service providers to ensure adequacy of project support and deliverables.
- Author, review and edit regulatory documents and packages for submissions to national regulatory authorities (NRAs) and/or scientific or executive management meetings.
- Build the Regulatory function that can support Phase 1, Phase 2 and Phase 3 clinical trials to product registration.
- Serve as lead writer for high priority submissions such as meeting briefing materials (slides/documents) and coordinate with service providers to ensure document publishing.
- Conversant with all aspects of the external regulatory environment, including upcoming regulations and regulatory positions, thereby providing the company with the necessary regulatory technical expertise and counsel to ensure success in developing its products. Ensure learnings shared with staff. Review and edit, as appropriate, press releases, presentations for external meetings.
Education and Experience Requirements
- Minimum of a B.A./B.S. within a technical related discipline is required. M.S., M.E., PhD or MD is a plus.
- Minimum 10 years of direct experience in a global regulatory affairs position and deep experience in product lifecycle management Phase 1 through post-approval.
- Strong knowledge of US and ICH regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
- A good understanding of IND, CTAand MAA processes.
- A proven ability to communicate and collaborate effectively with internal and external stakeholders.
- An accomplished professional with excellent skills in team leadership and problem solving.
- Excellent verbal and written communication skills.
- Travel for Work: Must be willing to travel approximately 10-20% post COVID-19.
Equal Employment Opportunity
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic