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Director of Regulatory Affairs and Precision Medicine Strategy

1 month ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
Purpose

Develop and execute a regional regulatory strategy for precision medicine and digital health assets, ensuring compliance with internal GSK processes and regional regulatory requirements. This role requires collaboration with global regulatory science and precision medicine teams, as well as regional regulatory affiliates.

Responsibilities and Accountabilities

Accountable for developing and delivering regional regulatory strategies for precision medicine and digital health assets, working closely with the global regulatory science and precision medicine teams. Key responsibilities include:

  1. Leading regulatory interactions and review processes for GSK.
  2. Ensuring compliance with regulatory requirements at all stages of product life, from C2MD.
  3. Advocating for regulatory approaches to senior leaders in GSK and health authorities.
  4. Providing assessments of precision medicine and digital health components for potential in-license molecules.

Required qualifications include a bachelor's degree in biological or healthcare science, extensive experience in regulatory considerations for companion diagnostics and/or SaMD, and experience with clinical trial and licensing requirements for precision medicine and digital health products in major countries.

Preferred qualifications include a PhD in a biological or healthcare science, excellent communication skills, and the ability to build strong personal networks within GSK and externally.