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Regulatory Consultant

Buckinghamshire   •  £50 - £85 per hour  •  Contract/Temporary, Full time


An excellent opportunity has arisen for an experienced Regulatory Consultant, with 5+ years of experience, to join my client based in Berkshire.  The contract will run for 6 months initially, with potential to extend. 
 
++ This contract falls outside of IR35 ++
KEY RESPONSIBILITIES:
 

  • Management of a product or specified products within a therapy area for Cosmetics, OTC and/or Medical Devices
  • Supports the Northern Cluster team (as appropriate) for UK, Ireland and Malta products
  • Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area
  • Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
  • Supports the team with regulatory strategies (local and regional) in line with business plan.
  • Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  • Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
  • Sign off of packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems etc.
  • Ensure Marketing Authorisations are maintained and renewed.
  • Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
  • Ensures compliance within the department by ensuring
  • Global, EAME and local databases are fully maintained.

 
 
QUALIFICATIONS & EXPERIENCE:

  • Life sciences or chemistry graduate to honours level or equivalent.
  • Works with minimal supervision to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
  • Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
  • May mentor Graduate and Regulatory Executive and provide day to day support (as appropriate).
  • Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc.

 
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk
 

  • Agency: Achieva Group Limited
  • Reference: BH-34436
  • Posted: 2nd March 2023
  • Expires: 30th March 2023

Achieva Group Limited

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