Associate Director, Regulatory CMC, Cell Therapy Combination Product (Boston)
Vertex Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Develops global CMC regulatory strategies for one or more investigational and/or marketed products
- Leads regulatory colleagues in development of global CMC regulatory strategies and submissions
- Provides CMC regulatory guidance to cross-functional teams and key stakeholders
- Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
- Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
- Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise
- Excellent interpersonal skills to communicate difficult concepts and persuade others
- Strategic thinking and strong problem solving skills
- Collaborates and communicates in an open, clear, complete, timely, and consistent manner
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines
- Experience with medical devices, specifically combination products is a plus.
- Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
- Typically requires 8 years of experience in the pharmaceutical or biotech industry or in a related field, or the equivalent combination of education and experience