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Senior Regulatory Associate, Global Regulatory Affairs

Hertfordshire   •  Permanent, Full time

CK Group is recruiting for a Senior Regulatory Associate, Global Regulatory Affairs to join Global Pharmaceutical company. Flexible working from home is available.

Senior Regulatory Associate Role:
? To focus on regulatory operational support for all stages of regulatory submissions including planning, compilation, production, submission, response to questions and approval
? Timely entry of regulatory activities into regulatory tracking systems, and the electronic trial master file (eTMF).
? To support the clinical development process for key compounds assigned by ensuring the timely submission of Clinical Trial Authorisation (CTA) applications and providing advice on EU regulatory clinical trial requirements to the International Project Teams (IPTs) or Regulatory Sub-team.
? To provide support to regulatory leads with regulatory submission preparations to regulatory agencies.

Your Background:
? Degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology or Pharmacology) or equivalent.
? Demonstrated experience with regulatory operational support, for example regulatory tracking systems and eTMF
? Familiarity with EU clinical trial regulatory processes
? Excellent written and verbal communication skills
? Strong problem-solving skills and eye for detail

Entitlement to work in the UK is essential. For more information or to apply for this Senior Regulatory Associate position, please contact Chloe Merrill on 01438 870 022 or email cmerrill@ckgroup.co.uk. Please quote reference 52237.

You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Chloe Merrill
  • Phone: 01246457700
  • Reference: 52237
  • Posted: 19th November 2021
  • Expires: 17th December 2021

CK Group

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