Senior Director Regulatory Affairs CMC
Company Summary:
My client, a leader in the biotechnology industry, focused on a new generation of compounds to help treat a variety of metabolic, oncological, and psychiatric diseases. They are experiencing a lot of growth, having added about 100 employees over the last year to their team of about 400. My client is located in Menlo Park, CA and is seeking a hybrid (3 days per week) Regulatory CMC Senior Director!
The Regulatory Affairs CMC Senior Director will be responsible for:
- Leading and overseeing preparation and submission of regulatory CMC dossiers and all other regulatory CMC activities in line with ICH and all other requirements.
- Overseeing the development and implementation of CMC regulatory strategies and managing ongoing submissions.
- Serving as the regulatory affairs representative and leading interactions with regulatory agencies for assigned programs.
- Providing CMC guidance to internal teams and leading cross-functional teams to prepare briefing packages and relevant sections for INDs, CTAs, NDAs/MAAs.
The Regulatory Affairs CMC Senior Director should have the following qualifications:
- Bachelor's degree with 15+ years of experience in drug development in the biopharmaceutical industry.
- 8+ years of experience in Regulatory Affairs (small molecule experience is desirable).
- Direct experience with submissions and product approvals, and regulatory filings such as IND/CTA or IND/MAA.
