Regulatory Affairs Consultant
CK Group are recruiting for a Regulatory Affairs Consultant to join a company in the Pharmaceutical industry at their site based in High Wycombe, on a contract basis for 6 months.
Salary:
Up to £64.18 per hour PAYE or £86.00 per hour via umbrella. This role is inside IR35.
Regulatory Affairs Consultant Role:
1. Management of post-approval activities for specified OTC products.
2. Support the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA.
3. Coordinate worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
4. Support the team with regional regulatory strategies in line with business plan for post-approval activities.
5. Ensure responses are submitted in a timely way in line with standard procedures and metrics.
6. May act as an ambassador for the Regulatory Affairs department to raise profile of team both internally and externally.
Your Background :
7. Hold a relevant degree in a life science or chemical subject.
8. Extensive working experience in the regulatory space, preferably with Over the Counter or FMCG.
9. Ability to work with minimal supervision to plan, conduct, and manage regulatory submissions for European.
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 based at our clients site in High Wycombe.