Senior Regulatory Affairs Consultant
My client is growing company committed to targeting a solution for a wide array of autoimmune disorders. They continue to build an extensive portfolio of products in immunology and oncology, monetizing selecting assets through active partnerships. Reporting to the Chief Medical Officer, you will be responsible for developing and directing regulatory strategy, objectives, policies, and programs from IND planning through NDA and commercialization.
Responsibilities:
- Responsible for implementing, maintaining, and overseeing audit-ready clinical quality systems
- Manage, hire and lead a team of regulatory and quality professionals to meet global development and regulatory requirements
- Serve as the regulatory lead; developing and providing strategic regulatory direction and guidance to R&D on corporate projects and key strategic business initiatives to achieve corporate objectives
- Create and lead the development of strategic and tactical plans in order to implement the creation and submission of regulatory documents as well as eventual regulatory filings to Agency.
Knowledge and Skills:
- Minimum BS in a life science discipline. Advanced degree preferred
- Minimum 15 years of experience in pharmaceutical/biotechnology industry with a minimum of 12 years spent in Regulatory Affairs
- Must have extensive experience working with the FDA and other regulatory authorities
- Proven track record of successful NDAs
- International regulatory submission experience
- Must have ODAC experience in oncology related therapies
- AD-Com experience preferred
Number of hours worked per week: 40 hours
Length of Assignment: 6 months
Position Location: South San Francisco, CA