Regulatory Affairs Specialist

  • Salary: Up to £56 LTD / £41 PAYE ph
  • REF Number: 00049911
  • Consultant: Lucy Stendall
  • Contact: 01246 457739
  • Date Published: 16.02.2021
  • Sector: Non-Specific
  • Location: Maidenhead, South East
  • Discipline: Regulatory Affairs

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.

Company: 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.

Location: This Regulatory Affairs Specialist role will be based at our clientssite in Maidenhead, Berkshire.

Salary: 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 portfoliorange.
  • 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.

Apply: For more information or to apply for this Regulatory Affairs Specialist position, please contact Lucy Stendall on01246 457739 or email pharmacontracts@ckagroup.co.uk, quoting job ref 49911.

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

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