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Regulatory Affairs CMC Manager

Regulatory Affairs CMC Manager

  • Location

    Boston, Massachusetts

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    23555_1619442035

  • Published:

    6 months ago

  • Expiry date:

    2021-05-29

  • Consultant:

    #

Job title: Regulatory Affairs CMC Manager (US Based - Multiple locations)

A Pharmaceutical Business based in Massachusetts are seeking a Regulatory Affairs CMC Manager to join their team. This role will be responsible for leading the coordination, prioritisation and tracking of regulatory activities and CMC submissions associated with the company's research, development, and post-marketing activities.

Responsibilities:

  • Develop and maintain detailed timelines for global regulatory activities and submissions for designated CMC projects to ensure timely delivery.
  • Work with Regulatory Regional leads to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable.
  • Ensure planning and coordination of activities to support regulatory submissions via the Regulatory Submission Team.
  • Contribute to budget preparation and resource planning.

Requirements:

  • Substantial experience within Regulatory affairs and Pharmaceutical industry.
  • Significant post approval experience working with multiple products/projects.
  • Proven experience in effective delivery of objectives in a complex matrix environment.
  • Experience in biologics would be beneficial.

Salary and benefits:

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

To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk