San Francisco, CA
3 months ago
Director/Senior Director, Regulatory Affairs
Location: San Francisco, CA
Type: Full Time Permanent
A Clinical-stage biopharmaceutical company focused on treatments for liver disease is looking to hire a Director or Senior Director, Regulatory Affairs. This company combines drug development and experimental combination therapy to advance its growing pipeline of small molecule medicines.
My client in the Bay Area is looking for a Director/Senior Director, Regulatory Affairs who will act as the Regulatory Lead by implementing the regulatory strategy and submissions. The individual will be responsible for liaising between the company and global regulatory authorities while ensuring compliance with all regulations.
- Contribute to product development strategies within cross-functional project teams with a particular focus on advancing combination therapies.
- Aim to develop regulatory strategies that can accelerate drug development in a fast-moving environment
- Plan, manage and develop documents for submission to regulatory authorities, including but not limited to IND’s, scientific FDA interactions (Type A/B/C meetings), CTA’s, protocol amendments, safety reports, and annual updates
- Act as a regulatory expert and source of regulatory information
- 5-7 years of experience in regulatory affairs
- Previous experience interacting with US FDA and being involved in complex negotiations
- Experience advancing clinical stage products through preclinical development, the IND process and toward product registration.
- Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements
- BA/BS Degree in a health/life sciences or related field. Advanced degree preferred