Director, Regulatory CMC - Cell & Gene Therapy

Job Description

General Summary:

The Director, Regulatory CMC leads a cross-functional team in the execution of global regulatory CMC strategies for investigational and marketed cell and gene therapy products. This role is accountable for the preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and marketed products.

Key Duties and Responsibilities:

• Oversees the preparation and review of CMC sections of regulatory submissions, and leads the interactions and responses with regulatory agencies
• Leads the development of global CMC regulatory strategies for multiple investigational and/or marketed products
• Leads the design, development and implementation of department strategies and contributes to the strategic planning for the area
• Ensures assigned projects are appropriately resourced and is accountable for the results of the team

Knowledge and Skills:

• Excellent interpersonal skills to influence others internally and/or externally and to negotiate with others in a limited capacity
• 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

Education and Experience:

• Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
• Typically requires 10 years of experience in the pharmaceutical or biotech industry or in a related field and 3 years of supervisory/cross-functional management experience, or the equivalent combination of education and experience

#LI-SV1 #LI-Hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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 ApplicationAssistance@vrtx.com