Regulatory CMC Professional

1 week ago


London, Greater London, United Kingdom Vertex Full time

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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