CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 12 months.
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 Manager role will be based at our clients site in Uxbridge, Greater London, but will be home based. Salary:
Competitive. Regulatory Affairs Manager Role:
- Ensure the client and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products.
- Ensure timely regulatory compliance with above approvals as requested.
- This role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade).
- Regulatory principles working with policies, procedures and SOPs.
- Knowledge of relevant legislation and regulations relating to medicinal products.
- Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
- Knowledge of drug development cultural awareness and sensitivity to achieve results across both regional country and International borders.
For more information or to apply for this Regulatory Affairs Manager position, please contact CK Group, quoting job ref 49044.
It is essential that applicants hold entitlement to work in the UK.