Senior Regulatory Programs Manager

1 month 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 building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Key Responsibilities:

  • Develop and implement the global regulatory strategy 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 strategy into regional submissions worldwide.
  • 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, clinical trials.
  • Awareness of post-marketing/brand optimization strategy, with track record of involvement in regulatory or pharmaceutical development in Phases I-IV, in multiple geographies.
  • Compliance and Quality mindset.
  • Fluency in English.

About Us:

We're a community of smart, passionate people dedicated to helping people with disease and their families. Our purpose is to reimagine medicine to improve and extend people's lives.

Why Join Us:

At SENIOR SPIRIT OF ROSELLE PARK, we offer a hybrid working environment, requiring 3 days per week in our London office. We're committed to building a diverse and inclusive team that represents the patients and communities we serve.

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