Role: EMEA Regulatory Affairs - ConsultantDuration: 5 MonthsLocation: High Wycombe, UK - Hybrid working (2/3 days in High Wycombe office)KEY RESPONSIBILITIESManagement 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. Ensures compliance within the department by ensuring EAME databases (RegPoint, HAQ) are fully maintained. Processes, SOPs, working instructions and Job Aids are adhered to. Update relevant document repositories (eg CEDMS, Teams etc.) to track current product information. Supports the EMEA RA team with ..... full job details .....