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Director-Sr. Director, Global Regulatory Affairs - Redwood City California
Company: Fusion Health Location: Redwood City, California
Posted On: 04/26/2024
At Biomea Fusion, Inc., we aim to cure in oncology and diabetes. We are seeking an experienced and highly motivated regulatory professional to support our clinical development programs and future marketing applications. Reporting to the Executive -Director, Regulatory Affairs, the Director/Sr. Director, Global Regulatory Affairs is the regulatory strategic leader on one or more clinical programs, responsible for developing and implementing innovative regulatory strategies for Biomea's clinical programs that have the potential to address critical unmet needs. This role is onsite at least 3-days per week. Essential Responsibilities: - Primary regulatory strategic advisor & team member for the product development team(s). Translates complex regulatory issues into actionable strategies. -
- Demonstrates an exceptional understanding of country requirements for investigational and marketing applications, i.e., INDs, NDA/BLAs, IMPDs, CTAs, DM, Fs, and MAAs - overseeing the planning and execution of those applications and subsequent submissions to regulatory authorities within the company requirements and timelines, regulations and guidelines.
- Assess situations and make and carry through complex decisions.
- Identifies future risks and provides solutions before the risks become a barrier to producing quality deliverables on time.
- Contributes to the strategic leadership and growth of the regulatory function, including developing processes and best practices commensurate with a rapidly growing company. -
- Limited travel may be required. -
- Listed responsibilities are an essential, but not exhaustive, list of the expected initial duties associated with the position. The role will evolve over time and changes to individual responsibilities may occur due to business needs.
Education and Experience Requirements: |
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