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.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 from home or at our clients site in Uxbridge, Greater London. Salary:
CompetitiveRegulatory 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.