Jane Griffin
- Role
- Senior Regulatory Affairs Manager at Ossium Health
- Location
- Berkeley, CA, US
- LinkedIn followers
- 500 followers
About Jane Griffin
Regulatory professional driven to bring innovative therapies to patients with…
Experience
Senior Regulatory Affairs Manager
Mar 2023 — Present
Advises on regulatory strategy for the development of cell therapy products • Leads cross-functional teams in the authoring, compiling, and filing of regulatory submissions, including meeting requests, initial INDs, IND amendments, orphan drug designation requests, and fast track designation requests • Oversees and monitors preclinical studies and CMC activities intended to enable IND submissions • Proactively identifies regulatory risks and develops mitigation plans • Monitors and interprets changes to global regulations and guidance, and provides regulatory advice to stakeholders
Skills
- Biopharmaceuticals
- Cell Culture
- Laboratory
- Life Sciences
- Lifesciences
- Pharmaceutical Industry
- Validation
- Gmp
- Quality Assurance
- Fda
- Quality System
- Technology Transfer
- Microbiology
- U.s. Food and Drug Administration (Fda)
- Protein Purification
- Sop
- Biotechnology
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