Regulatory Affairs Senior Manager

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:
Competitive

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.

Your Background:

• 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:
Quote job ref 48392.

It is essential that applicants hold entitlement to work in the UK.