Senior Director CMC Regulatory Affairs
Brief Position Summary
Provides CMC regulatory direction & strategic technical regulatory input across all programs to ensure that all CMC regulatory requirements / commitments are met with respect to development and approval of all Forum products.
This is a key, new, Regulatory role in a rapidly growing company which is currently in Phase III, with the opportunity for the candidate to play a significant role in the transition of the company through the pre-filing to commercialization phase.
Primary Position Responsibilities/Tasks
- Provide Regulatory direction for the coordination, preparation & submission of CMC regulatory applications consistent with corporate strategy & timelines
- Direct project-specific CMC communications/interactions with Regulatory Agencies (principally FDA) & act as primary regulatory contact for CMC regulatory matters
- Develop & execute CMC regulatory strategies and plans to achieve efficient product development and approvals
- Provide CMC regulatory input & direction for project teams to provide technical guidance & assist in problem solving or issue resolution
- Review/approve all CMC submission documentation prepared by other technical functions
- Review/approve internal CMC documentation to support development activities e.g. specifications, change controls, validation protocols etc.
- Monitor the development of new CMC requirements/expectations and advise Senior Management of the impact on the business and/or development activities
- Assist & participate as needed in Regulatory Authority facility inspections
- Pharmacist, Chemist or life-science graduate
- 15+ years experience in CMC Regulatory Affairs, or in a closely related field e.g. QA/QC, with 5+ years in a CMC Management role.
- Experience with oral small molecules
- Extensive hands-on experience and knowledge of the entire pharmaceutical development, submission & approval process (INDs, CTAs, NDAs & MAAs) & associated laws/regulations/guidelines, in both the US & EU
- Experience with direct interactions & negotiations with Regulatory Agencies, especially FDA
- Experience with Global regulatory filings would be a plus, e.g. Japan