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Salary:
Hourly 61.00 per hour PAYE or 82.00 per hour Umbrella.
Regulatory Affairs Manager Role:
Management of post-approval activities for specified OTC products
- Supports the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities for MRP/DCP products.
- Supports the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
- Supports the team with regional regulatory strategies in line with business plan for post-approval activities.
- Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
- Prepares and compiles regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
- Ensure Marketing Authorisations are maintained and renewed.
Your Background:
- Life sciences or chemistry graduate to honours level or equivalent.
- Works with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures 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.
- 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 2/3 days per week based in High Wycombe.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only) in all correspondence.
Please note:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
