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Associate Regulatory - CMC

Job description

Regulatory Associate

Do you have experience in regulatory submission or similar function?  Are you looking for a permanent role? Want to work for a leading Pharmaceutical client in Cork? Reach out today!

 

Job responsibilities:

  • You will partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes
  • You will partner with GRA-CMC Scientists to help build and manage submission contact, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions.
  • You will work within regulations to expedite the registration and lifecycle maintenance of products
  • You will implement and, in some cases, interpret global regulations and guidance and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements

 

Job requirements:

  • Bachelor’s Degree in a scientific or Health Science discipline (Pharma, Chemistry or related scientific discipline
  • Knowledge of pharmaceutical drug development or industry – related experience preferred

 

Additional Skills:

  • Drug development process or industry – related experience
  • Knowledge of Agency submissions procedures and practices
  • Ability to operate and manage operational requirements in a regulated environment

 

If you would like further information on this role, please send your CV to Louise Whitty lwhitty@sigmar.ie or call 021 2359140

 

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