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Senior Manager - Regulatory Strategy

  • Location

    New Jersey, USA

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    11655_1654090111

  • Published:

    about 1 month ago

  • Consultant:

    Freddie Hill

Job title: Senior Manager - Regulatory Strategy

A global pharmaceutical business in Cambridge, MA are seeking a Regulatory Affairs Senior Manager to join their team. In this role you will be responsible for leading the Global Regulatory Team (GRT) in the development of innovative and creative global regulatory strategies for pipeline and lifecycle assets in the company's growing and diversified oncology portfolio.

Responsibilities:

  • You will serve as the company's liaison to internal business partners including but not limited to the Global Project Team.
  • You will be accountable to lead the GRT and collaboratively develop and maintain the Global Regulatory Strategy.
  • Participate in the development and monitoring of the global regulatory environment and updating of standards and processes.
  • The role works with and participates on multi-disciplinary matrixed project teams to effectively meet project deliverables.

Requirements:

  • Extensive regulatory experience within the pharmaceutical industry, ideally in global regulations.
  • Demonstrated leadership experience with preparation of (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents and negotiating with a national/regional health authority.
  • Demonstrated strategic thinker with an ability to make complex decisions and willingness to defend difficult positions
  • A life sciences degree would be beneficial.

Salary and benefits:

A highly competitive salary and wider benefits scheme is on offer.