Regulatory Affairs Role Cork

Associate Director - Regulatory CMC

  • Posted Oct 18, 2021
  • Cork
  • Contract
  • BBBH24314

LSC have a great contract opportunity for an Associate Director - Regulatory CMC to join a Cork based Biopharmaceutical company.


  • Working closely with Quality Assurance, Quality Control and Manufacturing groups to assure the relevant product and regulatory expectations are met.
  • Act as the primary regulatory CMC contact with contract manufacturing organizations (CMOs) based in Europe.
  • Timely compilation and management of all necessary documentation for regulatory submissions.
  • Ensure submissions are of high quality; that content and format of regulatory submissions comply with application regulations and guidelines governing the development and marketing of drugs and/or biologics.
  • Provide regulatory CMC support for Impact assessment to change control, deviation and inspection management.
  • Coordinate and track regulatory commitments related to the site.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!

Apply via this advert or contact Kathy Gillen at LSC on 021-4777329 if you have anymore questions about this Associate Director - Regulatory CMC opportunity!

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
  • 95% of LSC contracts are renewed letting you choose contracting as a long term career option
  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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