Director, Regulatory CMC, Cell & Gene Therapy (Boston)
Vertex Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- Oversees the preparation and review of CMC sections of regulatory submissions, and supports the interactions and responses with regulatory agencies
- Leads and collaborates in the development of post-approval global CMC regulatory strategies for an approved cell and gene therapy product
- Leads and collaborates with individuals within Regulatory CMC to ensure robust and aligned CMC regulatory guidance is provided to cross-functional teams and stakeholders.
- Leads the design, development and implementation of department strategies and contributes to the strategic planning for the area
- Excellent interpersonal skills to influence others internally and/or externally and to negotiate with others
- Advanced strategic thinking and 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
- Comprehensive knowledge of regulatory (FDA, EMA, Health Canada and ICH) guidelines
- Experience with development and/or improvement of department processes/procedures
- Proven ability to impact and influence the decisions of a team and decision making committees
- Strong experience managing technical individuals in a matrixed environment
- Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, or another life-science field
- Requires 10 years of experience in the pharmaceutical or biotech industry or in a related field or the equivalent combination of education and experience. Cell and gene therapy experience is a plus.