Regulatory CMC Director or Associate Director
My client is boldly advancing a deep pipeline of highly targeted therapies against previously unaddressed drivers of disease, allowing patients to live longer with better quality of life. They are looking for a Regulatory CMC Director (or Associate Director) to lead CMC strategies for their upcoming INDs and eventual NDA filings. You should be able to understand the technical aspects of regulatory CMC while working with little oversight. You will have autonomy to resolve issues, make decisions, and contribute to registration strategies.
Responsibilities:
- Lead development and execution of global regulatory CMC strategy for assigned programs
- Make decisions on issues that could delay project schedules or activities; provide input on budget requirements; monitor project performance against goals
- Plan and lead preparation for key regulatory authority interactions
- Day to day management of regulatory CMC issues for multiple development programs
- Oversee and have accountability for all relevant submissions (INDs/CTAs/NDAs) and approvals for assigned programs
- Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs
Knowledge and Skills:
- Minimum BS in a scientific discipline, advanced degree preferred
- Minimum of 8 years of pharmaceutical experience with at least 5-8 years of direct experience in regulatory CMC
- Must have small molecule drug development experience, however, experience with both small and large molecule experience is acceptable
- Experience in oncology drug development preferred
- Experience working on an expedited (breakthrough or fast track designated) development program preferred
- Must have filed INDs, CTAs, and/or NDAs to FDA and ex-US regulatory agencies
- Late stage experience and/or NDA filing experience preferred
- Well-developed written and oral communication skills