Role: EMEA Regulatory Affairs - Consultant
Duration: 5 Months
Location: High Wycombe, UK - Hybrid working (2/3 days in High Wycombe office)
KEY RESPONSIBILITIES
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.
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 (...