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Senior Regulatory Programs Manager

2 months ago

London, Greater London, United Kingdom SENIOR SPIRIT OF ROSELLE PARK Full time
Senior Global Program Regulatory Manager

At SENIOR SPIRIT OF ROSELLE PARK, we're committed to delivering innovative solutions that improve people's lives. As a Senior Global Program Regulatory Manager, you'll play a critical role in shaping our regulatory strategy and ensuring compliance with global regulations.

Key Responsibilities:

  • Develop and implement global regulatory strategies for programs through development, registration, and post-approval in assigned regions.
  • Provide input to global program regulatory strategy, including regulatory designations and innovative approaches.
  • Coordinate regulatory readiness with other line functions, country organizations, and regions.
  • Lead planning, preparation, and submission of clinical trials and global registration strategies.
  • Ensure timely RA input and submission of regulatory compliance and maintenance reports.

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.
  • Compliance and quality mindset.
  • Fluency in English.

Why SENIOR SPIRIT OF ROSELLE PARK:

We're committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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