Regulatory Affairs Manager

CK Group are recruiting for a Regulatory Affairs Manager to join a company in the Pharmaceutical industry at their site based in High Wycombe, on a contract basis for 6 months.



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 105146 in all correspondence.


Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.