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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 ID: REQ

Location: United Kingdom

About the Role

As a Senior Global Program Regulatory Manager, you will play a key role in developing and implementing the global regulatory strategy for programs through development, registration, and post-approval in the assigned region(s). You will work with limited supervision to provide input to global program regulatory strategy, including regulatory designations and innovative approaches.

Key Responsibilities:

  • Coordinate regulatory readiness with other line functions, Country Organizations & Regions, representing RA or leads in regional RA or cross-functional activities.
  • Contribute to the development and maintenance of key documents, determining the requirements and coordinating the activity for HA interactions.
  • Lead planning, preparation, and submission of clinical trials, and the implementation of defined global registration strategy into regional submissions worldwide with country organizations.

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.

Division: Development

Business Unit: Innovative Medicines

Location: United Kingdom

Site: London (The Westworks)

Company / Legal Entity: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.