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 ++
- 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 firstname.lastname@example.org
- Agency: Achieva Group Limited
- Reference: BH-34436
Website: Achieva Group Limited
- Posted: 2nd March 2023
- Expires: 30th March 2023