Regulatory CMC Professional
1 week ago
About the Role
Vertex is seeking a highly skilled Regulatory CMC Professional to lead our global regulatory chemistry strategy. This exciting opportunity will involve influencing the execution of multi-product regulatory strategies, contributing to regulatory submission preparation, and providing regulatory guidance to cross-functional teams.
Key Responsibilities
- Capture and Evaluate Regulatory Knowledge: Stay up-to-date with FDA, EMA, Health Canada, and ICH guidelines to inform global regulatory CMC strategies.
- Develop and Execute Strategies: Collaborate with colleagues to develop and execute global regulatory CMC strategies for investigational and commercial products.
- Guide Cross-Functional Teams: Provide expert regulatory guidance to cross-functional teams to ensure compliance with global regulatory requirements.
Requirements
- Bachelor's degree in Biology, Chemistry, Pharmacy, or a related life-science field.
- Strong interpersonal skills to exchange complex information.
- Experience in the preparation of CMC submissions.
Salary Range
$120,000 - $150,000 per year, depending on experience.
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