Regulatory Affairs Role Cork

Regulatory Affairs CMC Manger

  • Posted May 10, 2022
  • Cork
  • Contract
  • BBBH25314

LSC have a great contract opportunity for a Regulatory Affairs CMC Manger to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • Represent regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
  • Timely compilation and management of all necessary documentation for regulatory submissions. Ensure submissions are high quality; the content and format of regulatory submissions comply with application regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics.
  • Liaise with U.S. and Shanbally teams to prepare GMP documentation to support global submissions for product registrations and/or renewals.
  • Participate in cross-functional project teams as a regulatory CMC representative for project specific discussions. Ensure consistent communication within the department and with other functional areas.
  • Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
  • Assist in the preparation for interactions with global regulatory authorities

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 Pawel Jurkiewicz at LSC on 021-4777329 if you have any more questions about this 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
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  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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