Senior Regulatory Programs Manager

4 weeks ago


London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full time
Senior Global Program Regulatory Manager

Job Summary:

We are seeking a highly skilled Senior Global Program Regulatory Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing the global regulatory strategy for programs through development, registration, and post-approval in assigned regions.

Main Responsibilities:

  • Provide input to global program regulatory strategy, including regulatory designations and innovative approaches.
  • Coordinate regulatory readiness with other line functions, Country Organizations, and Regions.
  • Contribute to the development and maintenance of key documents, including regulatory submissions and product information.

Requirements:

  • Science-based bachelor's or advanced degree, plus advanced understanding of pharmaceutical development and clinical trials.
  • Awareness of post-marketing/brand optimization strategy, with a track record of involvement in regulatory or pharmaceutical development in Phases I – IV, in multiple geographies.
  • Strong interpersonal skills and experience working in a complex, cross-functional organization and leading cross-functional teams.
  • Compliance and Quality mindset.
  • Fluency in English.

About Us:

At Advanced Accelerator Applications (Italy), we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.



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