Quality Assurance Role Cork

Regulatory Compliance Specialist

  • Posted Oct 5, 2022
  • Cork
  • Contract
  • BBBH25804

LSC has a great contract opportunity for Regulatory Compliance Specialist to join a leading biotech company based in Cork.

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • Co-ordinate SMEs for reviews of new product and post approval variations submissions to ensure that the JSI sections are accurate and consistent across all products.
  • Works with the Regulatory Manager to ensure Regulatory Playbook is maintained and updated in line with current product workflows.
  • In collaboration with Regulatory Management, coordinating the Change Summaries for submission in the product Annual Reports, as required.
  • Familiarization with license content and license sections in eCTD viewer and work with both the QPs and Regulatory Manager to ensure transparency of information and escalation information is shared.
  • Regulatory support for routine manufacturing / Quality operations.
  • Knowledgeable on regulatory systems such as ERIS, RIACS, GRAIL, RIMDocs, eCTD, etc
  • In collaboration with Regulatory Management, ensure maintenance of the commercial and clinical manufacturers licenses
  • Notarization and legalization management.
  • In collaboration with Regulatory Management, works on completing country specific registration, re-registration, accreditation requests.

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 Siobhan Cummins at 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
  • 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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