Regulatory Affairs Senior Manager
CK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company 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 at our clients site in Uxbridge, Greater London.
- 49.15 per hour PAYE.
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.
Apply: For more information or to apply for this Regulatory Affairs Senior Manager position, please contact Julie Marshall on 01438 870011 or email email@example.com, quoting job ref 48392.It is essential that applicants hold entitlement to work in the UK.