Regulatory CMC Leadership Opportunity at Vertex Pharmaceuticals
6 days ago
The Chemistry Manufacturing Controls Senior Manager will play a critical role in executing global regulatory CMC strategies for investigational and marketed products. This position is responsible for leading the preparation and submission of regulatory CMC documentation, managing interactions with Health Authorities, and providing regulatory support to cross-functional teams.
About the Role
This leadership opportunity requires a senior professional with expertise in regulatory affairs, strategic thinking, and strong problem-solving skills. The ideal candidate will have 6+ years of experience in the pharmaceutical industry or related field, with a focus on regulatory CMC submissions, strategic planning, and team leadership.
Key Responsibilities
- Prepare and review CMC sections of regulatory submissions.
- Develop global regulatory CMC strategies for investigational and/or commercial products.
- Collaborate with regulatory colleagues on global regulatory CMC strategies and submissions.
- Provide regulatory CMC guidance to cross-functional teams and key stakeholders.
- Manage regulatory assessment and guidance on product compliance topics.
Requirements
- Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field.
- Strong understanding of cGMP, FDA, EMA, and ICH guidelines.
- Proficiency in regulatory (FDA, EMA, Health Canada, and ICH) guidelines.
About Us
Vertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation. We are 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.
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