San Francisco, CA
about 1 month ago
Associate Director Regulatory Affairs- San Francisco, CA
Specific Responsibilities and skills for Position
- Responsible for preparing and/or overseeing the preparation of regulatory submissions which require collaboration with other teams
- Responsible for the submission of regulatory documents such as: safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories.
- Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products.
Contributes to the regulatory review of draft Product Company Core Safety Information (CCSI) and ensures updates to the CCDS or CCSI are implemented.
- Provides strategic regulatory advice as appropriate.
- Ensures knowledge of regulatory requirements are up to date, provides new regulatory guidance when possible, and conveys changes in regulatory information to project and management teams.
- Responsible for creation and implementation of regulatory strategies and overseeing negotiations with regulatory bodies.
- Able to lead a small team in preparing submissions and maintaining licenses.
- Able to act as primary Company contact with Regulatory Authorities.
Knowledge, Experience and Skills
- Advanced Science Degree preferred (PhD, PharmD, MD, MSc)
- 10+ years of overall regulatory experience
- Global regulatory lead experience required
- Experience in inflammation, rheumatology, immunology, or dermatology required
- Previous people management experience is desirable.