EMEA Regulatory Affairs Contract or- Pharmaceuticals - 6-Month Contract
Our client have an exciting new opportunity for a regulatory affairs contractor 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:
1. 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.
2. Supports the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
3. Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
4. 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.
5. EAME databases (RegPoint, HAQ) are fully maintained.
Requirements:
6. Life sciences or chemistry graduate to honours level or equivalent.
7. Works with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
8. Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
9. 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
10. Hybrid. 1 - 2 days in the office per week
If this role is of interest to you, please apply now!
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