- 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.
Director, Regulatory CMC, Cell - Boston, MA, United States - Vertex Pharmaceuticals
Description
Director, Regulatory CMC, Cell & Gene Therapy (Boston) page is loaded
Director, Regulatory CMC, Cell & Gene Therapy (Boston)
Apply locations Boston, MA time type Full time posted on Posted 4 Days Ago job requisition id REQ-21607Job Description
General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into a marketed cell and gene therapy product.
Key Duties and Responsibilities:
Knowledge and Skills:
Education and Experience:
We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:
1. Hybrid and work remotely up to two days per week; or select
2. On-Site and work 5 days per week with ad hoc flexibility.
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at