Job Summary
A pharmaceutical company needs applicants for an opening for a Remote CMC Regulatory Director.
Candidates will be responsible for the following:
- Moduling 3/CMC documents with the view of an FDA product reviewer for successful filings
- Providing strategic CMC regulatory guidance to all stakeholders with a view towards achieving successful negotiations with FDA and global health authorities
- Ensuring up to speed on current and changing CMC regulatory guidance, and regulations (within FDA, ICH, and globally)
Skills and Requirements Include:
- Bachelor’s degree
- Minimum 10 years hands-on proven CMC-Regulatory experience in both pharmaceutical industry (small to mid-size preferred) and consulting with PhD or 15 years’ experience with Bachelor’s degree or higher
- Proven history of successful negotiations with the FDA and global health authorities; negotiations to approval important but not essential
- Strong management experience leading and mentoring Regulatory projects and mentoring clients or team members
- Excellent verbal and written communication skills with the ability to engage, negotiate, influence, and gain consensus across multiple functions
- Highly organized with the ability to execute and deliver on multiple tasks and projects within given deadlines
