2 months ago
A well funded pre-IPO Biotech startup in the San Fransisco Bay area is looking for a Head of Regulatory Affairs to establish the Regulatory Vision and provide a strategic pathway. You will report directly to C-suite, and will be the main FDA liason. This is an opportunity to make a huge impact, and drive forward an exciting Biotech in its initial stages. Assets are already in Play, with a BLA to be submitted by end of year.
- Serve as the point of contact with major Health Authorities including FDA.
- Represent Regulatory Affairs with various internal departments to manage activities and coordinate in the preparation of regulatory submissions
- Provide strategic regulatory advice and speak with key stakeholders
- Help with compound registration and follow-up closely on approvals of product registration and variations.
- Build the Regulatory function, and advise C-suite on Regulatory pathways.
- Minimum of 12+ years regulatory experience
- MBA + PhD/PhS/MD Strongly Preferred
- BLA Submission experience required
- Orphan Drug Designation experience a plus
- Existing relationships with the FDA and other Health Reviewers preferred
- Must be on-site near San Fransisco, comrehensive relocation package will be offfered
If you are interested in more information, please reach out to Ryan at 347-305-6781 or firstname.lastname@example.org