Global Regulatory Strategy Manager

3 days 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 seeking a talented Global Regulatory Strategy Manager to join our team. As a key member of our Regulatory Affairs department, you'll play a crucial role in developing and implementing global regulatory strategies for our programs.

Key Responsibilities:

  • Develop and implement global regulatory strategies for program(s) 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.
  • Contribute to the development and maintenance of key documents 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 and 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:

Senior Spirit of Roselle Park is a company that's deeply committed to helping people with disease and their families. We're passionate about innovation, collaboration, and making a real difference in people's lives.

As a member of our team, you'll have the opportunity to work with talented individuals who share your passion for regulatory affairs and pharmaceutical development.

Why Join Us:

At Senior Spirit of Roselle Park, we're dedicated to creating a brighter future for everyone. We believe in the power of collaboration, innovation, and a commitment to excellence.

Apply now to become a part of our team and help us bring new medicines to patients faster.

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