Job Description

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:

✉: ryan.moran@peoplewithchemistry.com

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