Senior Manager, Regulatory CMC
Vertex Pharmaceuticals Incorporated | |
United States, Massachusetts, Boston | |
50 Northern Avenue (Show on map) | |
Sep 27, 2024 | |
Job Description General Summary: The Chemistry Manufacturing Controls Senior Manager will participate in the execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and submission of regulatory CMC documentation and manages interactions with Health Authorities for CMC topics. This role also acts as a resource for regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs. 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 canchoose to work: 1.Hybridand work remotely up to two days per week;or select 2.On-Site andwork 5 days per week with ad hoc flexibility. #LI-AR1 #LI-Hybrid Flex Designation: Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 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 |