Regulatory Affairs Senior Manager - New Works, United Kingdom - CK GROUP

CK GROUP

Verified Company

New Works, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company, who are based in Uxbridge and Cambridge on a contract basis for 12 months.

This role is inside IR35, and allows for remote working.

Rates:

Up to £70 per hour Umbrella.

The 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 geneticsto unravel the complexities of disease and understand the fundamentals of human biology.

Location:

The role is remote based position but the office team location is Uxbridge and Cambridge. Ideally you should be able to travel into the office occasionally for meetings.

Regulatory Affairs Manager:

Ensure that the company 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 to ensure timely regulatory compliance with above approvals.

Responsibilities:

Advising on regional considerations in developing strategy ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
Direct the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.

Experience Required: