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Senior Regulatory Programs Manager

2 months 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.

About the Role:

Key Responsibilities:

  • Develop and implement global regulatory strategy for programs, including regulatory designations and innovative approaches.
  • Coordinate regulatory readiness with other line functions, country organizations, and regions, representing RA or leading in regional RA or cross-functional activities.
  • Contribute to the development and maintenance of key documents, determine requirements, and coordinate HA interactions.

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.

Why Novartis:

At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

We offer a collaborative and dynamic work environment, with opportunities for professional growth and development.

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