CK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company either remotely or 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 either remotely or at our clients site in Uxbridge, Greater London. Salary:
Competitive 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) forprocedures 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.
- Experience of working directly with the EMAand Centralised Procedure.
- Experience in Inflammation, Cardiovascular, Bone, therapeutic area.
- Experience working with biotechnology products.
Quote job ref 48928.
It is essential that applicants hold entitlement to work in the UK.