EMEA Regulatory Affairs - Reguatory Consultant - Pharmaceuticals - 12-Month Contract Our client has an exciting new opportunity for a X to join the team. Our client has specialised in pharmaceutical products and people's well-being for over a century and work with some well-known household brands.
Responsibilities:
- 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.
Requirements:
- 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
- 2/3 days on site in High Wycombe
If this role is of interest to you, please apply now!
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