7 months ago
Director, Global Regulatory Lead
Location: San Francisco
Type: Permanent Position
My client in the Bay Area is a clinical stage Biotechnology company working on personalized immunotherapies to treat solid tumors. This is a great opportunity to join a growing company and have the opportunity to be the Regulatory Lead for their 2 products in Phase 1, both of which are in collaboration with a leading Pharmaceutical company.
The Director, Global Regulatory Affairs will be responsible for the development and execution of the global regulatory strategy. This professional will also be responsible for the management of the global regulatory team to ensure accurate and timely submissions of IND/CTA/BLA/MAA for assigned products.
- Represent global strategic input in Product development meetings
- Provide strategic input to ensure timely registration and successful product development
- Responsible for the interactions with Global Health Authorities, including writing regulatory documents
- Leads submissions to ensure timing, content, and review cycles meet business objectives
- Participates in departmental meetings to address internal and external regulatory needs and requirements
- Manage regulatory staff
- Support development and implementation of new or updated Regulatory systems, processes and Standard Operating Procedures (SOPs)
- Bachelors or Advanced degree with 6-8 years' experience Regulatory Affairs (or BS with 12-14 years' relevant experience)
- Previous experience as a Regulatory Lead responsible for the global regulatory strategy
- Knowledge of Biologics, preferred experience in gene therapy programs
- Familiar with regulations and procedures of companion diagnostics, PMA, GAMP
- Previous experience leading meetings with Health Authorities.
I am a Regulatory Affairs market expert working with a large variety of clients across the Biotech and Pharmaceutical industries. If this role isn’t of interest to you, but you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Nikita Madan at 619-350-6341 or at firstname.lastname@example.org