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Regulatory Affairs CMC Specialist - 12 month contract

Regulatory Affairs CMC Specialist - 12 month contract

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    23081_1615800110

  • Published:

    8 months ago

  • Duration:

    12 months

  • Expiry date:

    2021-04-14

  • Consultant:

    #

Job title: CMC Regulatory Affairs Specialist

A Neurology/Immunology Pharmaceutical Company based in Berkshire are seeking a Regulatory Affairs CMC specialist to join on a contract basis. This role will provide support, or lead as assigned, regulatory CMC submissions for all global development products.

Responsibilities:

  • Support for developing and implementing the regional CMC regulatory strategy and submission plans for assigned projects/products
  • Responsible for writing regional and global CMC documentation for submissions as agreed with the Global Regulatory CMC Lead
  • Contribute to the preparation of the CMC SWOT analysis (or regulatory Risk Capture Document) and supports associated RA CMC challenge sessions.
  • Provides regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Trackwise, UPILOT etc.)
  • Leads or provides support to cross-functional teams responsible for the preparation of responses to HA CMC questions raised

Requirements:

  • At least 5-8 years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity
  • Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
  • Experience of participating in regulatory agency meetings on CMC matters
    Knowledge of GMP requirements and standard systems

This is a 12-month contract offering an attractive hourly rate for both PAYE and LTD/Umbrella contractors.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk