about 2 months ago
Manager, Regulatory Affairs
Location: San Francisco, CA
Type: Permanent Position
My client in the Bay area is a precision medicine company focused on cancer and rare diseases. They are looking for a skilled Manager, Regulatory Affairs who will be responsible for supporting the regulatory activities including preparation of submissions to regulatory agencies, and managing timelines. This position will report into the Director, Regulatory Affairs.
- Responsible for all regulatory activities, including clinical trial application (CTA) and IND submission
- Inform the study team of regulatory activities at management meetings
- Monitor queries with regulatory agencies, work with subject matter experts to provide written responses, provide status updates for unfulfilled conditions/commitments
- Work with team members to plan for regulatory documents, including responses to Health Authority queries
- Support the review, finalizaion, and signing off of regulatory submissions and managing the track record of regulatory submissions and approvals across all studies
- Bachelor's degree or higher biological or physical sciences
- 2-4 years of Regulatory Affairs experience
- Knowledge of US FDA and international pharmaceutical regulations and drug development processes.
I am a Regulatory Affairs market expert working with a large variety of clients across the Biotech and Pharmaceutical industries. If this role isn’t of interest to you, but you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Nikita Madan at 619-350-6341 or at firstname.lastname@example.org