CK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company either from home or at their site based in Uxbridge on a 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.
This Regulatory Affairs Senior Manager role will be based from home or at our clients site in Uxbridge, Greater London.
Regulatory Affairs Senior Manager Role:
- Ensure that the business acquires and maintains all the required licenses 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).
- Advising on regional considerations in developing strategy.
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
- Regulatory knowledge in regional legislation.
- Working with policies, procedures and SOPs Experience with national legislation and regulations relating to medicinal products.
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
- Understanding of drug development.
Quote job ref 48392.
It is essential that applicants hold entitlement to work in the UK.
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- Agency: CK Group
- Contact: Julie Marshall
- Phone: 01438 723 500
- Reference: 48392
- Updated: 9th October 2020
- Expires: 6th November 2020