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| Job Location | Uxbridge |
| Education | Not Mentioned |
| Salary | Salary negotiable |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent, full-time |
CK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 12 months.Company:Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.Location: This Regulatory Affairs Senior Manager role will be based at our clients site in Uxbridge, Greater London. Salary:£49 per hour PAYE.Regulatory Affairs Senior Manager Role:- This role will provide regional regulatory support for one or more products.- As a member of the Global Regulatory Team (GRT), the incumbent will be accountable for developing and executing regional regulatory strategies across the product lifecycle and managing effective agency interactions.- Define and advise the GRT on regional considerations in developing creative regulatory strategy.- Ensure European regional needs are well defined and implemented in collaboration with relevant regional stakeholders.- Develop and implement regulatory strategy and executional plans, and manages regulatory submissions (e.g. clinical trial and marketing applications) for assigned products in accordance with global filing plans, core labelling documents and regulatory requirements.Your Background:Essential requirements:- The individual should have a proven track record supporting the diversity of regulatory procedures in the EU (inc. PIPs, variations, IMPDs, MAAs) and ability to work autonomously.- Experience with national legislation and regional regulations relating to medicinal products.- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage.Preferred experience:- Experience of working directly with the EMA and Centralised Procedure.- Experience in Inflammation, Cardiovascular, Bone, therapeutic area.- Experience working with biotechnology products.Apply:For more information or to apply for this Regulatory Affairs Senior Manager position, please contact CK Group, quoting job ref 48928.It is essential that applicants hold entitlement to work in the UK.