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Regulatory Affairs Specialist

Berkshire SL6   •  Contract/Temporary, Full time

CK Group are recruiting for a Regulatory Affairs Specialist to join a company in the Pharmaceutical industry at their site based in Maidenhead on a contract basis for 6 months.
Our client is part of one of the largest Pharmaceutical companies in the world. Their consumer segment includes a broad range of products used in the baby care, skin care, oral care, wound care and women\'s health care fields.

This Regulatory Affairs Specialist role will be based at our clients site in Maidenhead, Berkshire.

Up to £56 per hour LTD or £41 per hour PAYE.

Regulatory Affairs Specialist Role:

  • Support the Northern Europe Cluster team (as appropriate) for UK, Ireland & Malta across the Consumer Health portfolio range.
  • Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
  • Define regulatory strategies (local and regional) in line with business plan.
  • Complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  • Prepare and compile regulatory submissions (Marketing Authorisations Applications, Renewals Variations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU & UK regulations and guidelines.

Your Background:

  • Life Sciences or Chemistry graduate to honours level or equivalent.
  • Must have UK market regulatory experience within pharmaceutical regulatory affairs and working with MHRA directly, ideally with some OTC experience.
  • Brexit related regulatory knowledge and experience.
  • Must have hands on experience in management of day to day UK and EU regulatory procedures.
  • Ideally knowledge and experience of allied regulatory affairs areas such as Cosmetic, Medical Devices but not essential.

For more information or to apply for this Regulatory Affairs Specialist position, please contact CK Group, quoting job ref 49911.

It is essential that applicants hold entitlement to work in the UK.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Lucy Stendall
  • Phone: 01246 457733
  • Reference: 49911
  • Posted: 16th February 2021
  • Expires: 16th March 2021

CK Group

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