Regulatory CMC Manager
Vertex Pharmaceuticals•Boston, MA
•$75 - $80
About The Position
The Chemistry Manufacturing Controls Manager will support the execution of multi-product global regulatory CMC for marketed products. This role contributes to the preparation and submission of regulatory CMC documentation including clinical trial submissions and provides regulatory support to various cross functional teams with a focus on Biologics.
Requirements
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
- Strong problem-solving skills
- Ability to collaborate and communicate 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
- Sound knowledge of cGMP, FDA, EMA, ICH
Responsibilities
- Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU.
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
- Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
Benefits
- medical benefits
- fringe benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
