Vacancy expired!
- Serve as regulatory representative for assigned clinical studies and provide representation for study-level regulatory activities.
- Manages and tracks queries from, and commitments to regulatory agencies, collaborates with SMEs to provide written responses to Health Authority queries, and provides periodic status updates regarding unfulfilled conditions/commitments.
- Coordinates the authoring, review, and approval of Clinical, and Nonclinical documents for submission to Health Authorities (INDs, CTAs, amendments, annual reports, meeting packages, etc.)
- Provides support to senior Regulatory Affairs staff and management as needed.
- Supports processes by which regulatory submissions are reviewed, finalized, and signed-off.
- Participates in cross-functional sub-teams and working groups.
- Contributes to the development and maintenance of the Regulatory Affairs working practices and procedures.
- Maintains knowledge of global regulatory environment, regulations, and guidelines
- Manages document archive processes.
- Supports QC activities as needed.
- Minimum of a BA/BS degree in an appropriate scientific or other related field
- Must live with in commuting distance from Newark, CA (hybrid work schedule)
- 4+ years of relevant pharmaceutical industry, direct experience in regulatory affairs
- Knowledgeable of international pharmaceutical guidance, regulations, drug development process, and industry standard practices
- Detail oriented with excellent oral and written communication skills
- Strong team player, self-motivated and able to function independently as well as part of a team
- Able to work on multiple projects concurrently and adapt to a continuously changing environment
- Proficient in organization, prioritization, and time management
Vacancy expired!