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Salary:
Hourly rate up to 62.93 PAYE (inside IR35).
Regulatory Affairs Manager Role:
- Management of a product or specified products within a therapy area for OTC Medicines, Cosmetics, Medical Devices and/or Food Supplements.
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
- Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency 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 the relevant internal systems.
- Ensure Marketing Authorisations are maintained and renewed.
Your Background:
- Life sciences or chemistry graduate to honours level or equivalent.
- Experience of the plan, conduct, and management of regulatory submissions and multiple projects to meet department and company objectives.
- Able to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
- Must have experience of OTC medicines. Useful if you have experience of cosmetics, medical devices and/or food supplements but not essential.
- 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.
Company:
Our client is the largest and most broadly-based healthcare company. They strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.
Location:
This role is hybrid working with 1-2 days per week based at our clients site in High Wycombe.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (phone number removed) in all correspondence.
Please note:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
