Director Regulatory CMC
We are looking for a Director of Regulatory CMC to join a clinical stage biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics. My client has five clinical-stage development programs focused on a variety of cognitive impairments and compulsive disorders. The Director of Regulatory CMC will be the key person leading the CMC regulatory activities in support of CMC sections and eventual NDA filings. This is an exciting company with a deep pipeline and proprietary research platform.
Responsibilities:
- Contribute to the development of CMC regulatory strategies for multiple programs in development
- Give strategic input to the CMC & QA teams on what information is needed for different types of filings
- Streamline and create efficient CMC sections in support of NDA filings
- Assess where risks can be taken looking at that risk what the gap analysis would be and providing a path forward
- Coordinate the preparation of CMC submissions through editing and approval of final draft documents including review for quality
- Interact with domestic and foreign regulatory agencies on CMC issues
- Ensure submissions are reviewer friendly with the most efficient ways to get things done on time and on budget
- Negotiating, interacting with, and supervising the activities of contract manufacturing organizations (CMO’s) in the preparation of regulatory submissions
Knowledge and Skills:
- BS/MS degree in Chemistry or in a scientific discipline
- Minimum of 10 years’ experience in the pharmaceutical industry with a minimum of five years spent in Regulatory CMC
- Significant experience interacting with at least one major health agency (FDA, Health Canada or EMA); interactions with one or more major health agencies desired
- A comprehensive understanding of CMC regulatory requirements including FDA and ICH guidelines and relevant government regulations as they apply to the registration, development and approval of investigational products as well as post approval changes to marketed products
- A demonstrated ability to contribute regulatory CMC expertise and advice
- Excellent interpersonal, verbal and written communication skills
- Leadership qualities: ethics, integrity, creativity, collaboration