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Go to next pageMeet Life Sciences - South San Francisco
Work at Meet Life Sciences
Director, Regulatory Affairs
*Hybrid Role - 2-3x per week onsite in South San Francisco*
Meet has partnered with an exciting biotech that is looking for a Director of Regulatory Affairs to join their team. Our client is focused in developing treatments for rare hematology/immunology indications and has several clinical-stage programs. Our team placed the hiring manager (SVP Regulatory Affairs) and a Director of RA in this function and both have had wonderful things to say about the organization.
Key Responsibilities
- Lead the development and implementation of strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
- Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
- Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities
Key Qualifications
- 8+ years of pharmaceutical Regulatory Affairs experience
- Experience supporting/leading major regulatory submissions required (IND/CTA, NDA/BLA/MAA)
- Oncology/hematology experience required
- Small biotech experience strongly preferred
Please reach out to Ryan Moran if you're interested in learning more:
✉:
See details and apply
Director, Regulatory Affairs
