Regulatory Affairs ManagerCK 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 to the end of March 2025.
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.