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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 Regulatory Manager

At Advanced Accelerator Applications (Italy), we are seeking a highly skilled Senior Global Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will play a critical role in developing and implementing the global regulatory strategy for our programs.

Key Responsibilities:

  • Develop and implement global regulatory strategies for programs through development, registration, and post-approval in assigned regions.
  • Act as RA program lead on programs of limited complexity and provide input to global program regulatory strategy.
  • Coordinate regulatory readiness with other line functions, country organizations, and regions, representing RA or leads 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.

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. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.