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Regulatory Affairs Manager

Regulatory Affairs Manager

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Regulatory Affairs Manager

  • Location:

    England

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Arslan Sabir

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/04123_1669051685

  • Published:

    17 days ago

  • Duration:

    12 Months

  • Startdate:

    ASAP

MSI Pharma are looking to hire a CMC Regulatory Affairs Specialist for a UK based pharmaceutical firm. This is a contract role and can be worked fully remotely from anywhere in the UK

Responsibilites:

  • Manage the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle; including clinical programs marketing authorisation applications and all post approval approval activities
  • Accountable for delivering "submission ready" CMC modules to internal and external regulatory stakeholders in compliance with relevant systems and procedures and ensuring submission quality.
  • Documenting maintenance and communication of Health Authority approval status.
  • Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
  • Project management expertise with the ability to adapt to changing situations to ensure on time delivery.
  • Ensure the learning from own projects are shared with other colleagues/within the functions.

Education and Experience:

  • University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.
  • Breadth of knowledge of manufacturing, project, technical and regulatory management.
  • Knowledge of the drug development process and regulatory submissions.
  • Understanding of current regulatory CMC requirements
  • Oncology Experience