BD - 60
10 days ago
Senior Director Regulatory Affairs – Oncology
Location: San Francisco OR San Diego, CA
Type: Full Time Permanent
Salary: Excellent salary, bonus and accompanying benefits package (Relocation provided for exceptional candidates)
Exciting opportunity to completely own the Module 3 and provide CMC strategy from an exectuve level for a strong clinical biotech who is focused in oncology and looking to file their first NDA/BLA end of year!
The Director of Regulatory Affairs CMC will be responsible in providing and developing strategic direction within CMC with the intention of successful registration. This person will provide leadership and a sense of urgency to cross-functional teams, as well communicating with FDA and other regulatory agencies with respect to CMC.
- Provide regulatory CMC leadership for all drug development projects to health authorities for regulatory submissions
- Serve as liaison between FDA and company for all CMC discussion/negotiations
- Define and develop CMC regulatory strategies
- Coordinating all CMC documentations submitted to FDA in support of INDs, BLAs, MAAs, DMFs, CTAs, amendment and annual updates
- MS required (PhD, MD, PharmD, or MS preferred) with proper experience.
- 8-10 years of regulatory submission experience/ biopharma arena
- Experience with manufacturing, process development, quality control, or quality assurance
- Prior experience and success with filing BLAs/MAAs
- Prior experience preparing CMC regulatory documents including new INDs/amendments
- Well-rounded knowledge of FDA regulations and EU CTA requirements
- Demonstration of strategic planning, meeting objectives, technical and resource issue resolution
- CMC specific regulatory knowledge and an understanding of manufacturing, process development, quality control, or quality assurance related to biologics, small molecules, biosimilars, and/or combination products
I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Bobby DeMarco at (646)-349-4344 or at firstname.lastname@example.org