As Director/Executive Director, Regulatory Affairs, you will be responsible for developing, leading, and implementing global regulatory strategies for Biomea Fusion’s products in coordination with key internal stakeholders. This position will lead and manage regulatory CMC aspects through all phases of development (IND filing through approval), post-approval, and life-cycle of the product.
Primary responsibilities entail creating CMC regulatory strategies for development programs in preparation and maintenance of regulatory applications.
- Serve as Company Representative for FDA and other regulatory authorities.
- Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of INDs/CTAs/marketing applications.
- Develop regulatory strategic plans and assist in the design of nonclinical and clinical study programs required for regulatory approval.
- Manage/prepare IND submissions in eCTD format (oncology, immunology).
- Manage/review filing of pre-IND, EOP2, Type C meeting requests/meeting packages, NDA FDA requests for information, NDA annual report and 120-day safety update, routine submissions including safety reporting, investigator packages, annual reports (paper and electronic).
- Serve as point of contact for eCTD publishing vendors and other external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions.
- Ability to manage global Phase 2 and Phase 3 clinical studies.
- Attend SMT, PDT, ad hoc meetings as a regulatory representative.
- Provide interpretation of regulatory authority feedback, policies, and guidelines to Biomea personnel, and serve as a liaison between Biomea and regulatory authorities.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
- Work with internal stakeholders to resolve complex project issues.
- Provide organizational support and be prepared to manage personnel as the company grows its product development pipeline.
Education and Experience Requirements:
- A 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 7 years of direct experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in product lifecycle management from Phase 1 through commercial and post-approval.
- Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
- A good understanding of IND, CTA, BLA and MAA processes.
- Expertise in commercial product lifecycle as well as Phase 1-3.
- A proven ability to communicate cross-functionally in a fast-paced environment is crucial.
- An accomplished professional with excellent skills in team leadership and problem solving with regard to regulatory issues.
- Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including FDA and other Health Authorities.
- Excellent verbal and written communication skills.
- Demonstrated ability to prioritize and handle multiple projects simultaneously.
- Ability to apply a high level of ethics.
- Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint, Teams), GANT charting with timelines desired.
- 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.