CK Group are recruiting for a Senior Manager Regulatory Affairs to join a biopharmaceutical company who are based in Uxbridge or Cambridge 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. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Location:
The role is based in Uxbridge or Cambridge and offers hybrid/remote working.
Hourly Rate:
£48.92phr PAYE or £64.85phr Umbrella.
Role:
To maintain all the required licenses in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products to ensure timely regulatory compliance with above approvals.
Advise the Global team on regional considerations in developing strategy ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
Manage regulatory submissions (e.g. clinical trial and marketing applications) for products in compliance with global filing plans and local regulatory requirements.
Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
Provide regulatory...