Senior Director Regulatory CMC
My client is a world-wide leader in treatment for rare life-threatening diseases. With a major FDA approval earlier this year and several clinical-stage pipeline programs, they are in a prime position for rapid growth over the next five years. My client is in need of a Senior Director Regulatory CMC to oversee their regulatory CMC team and lead global CMC strategies for both development and approved programs. You will report directly to the Senior Vice President of Regulatory Affairs and Quality; interacting with global Agencies and executive leadership on a regular basis. The ideal Senior Director will thrive in a company where the pace is fast and ambiguity is a regular day at the office.
Responsibilities:
- Build and lead the Regulatory CMC team
- Provide product strategy and direction to commercial and clinical teams
- Assure the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality
- Assess complex issues and strategies into actionable items as a lead of project teams
- Formalize CMC processes by assessing existing structure and proposing additional needs/staff
- Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
- Oversee the preparation, review and submission of CMC and marketing registration applications, supplements and variations
Knowledge and Skills:
- Minimum BS in a scientific discipline required; advanced degree preferred
- 10 years spent in leading regulatory CMC activities in support of FDA and ex-US agencies
- Lead project teams-internally and externally
- Experience with early to late drug development
- Regulatory experience supporting both development projects and marketed products
- Must be a team player
- Must communicate with all levels of the department