Regulatory Affairs Manager

CK Group have an opportunity for a Regulatory Affairs Manager, to join a global pharmaceutical company, on a 12-month contract basis, on site in Uxbridge.

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 .

Rates:

Hourly: Up to £43.94 PAYE

Location:

The role is hybrid. The office team locations are Uxbridge and Cambridge, so we'd be looking for candidates in this vicinity.

Responsibilities:

• Execute the regional regulatory strategy and regional regulatory plans.
• Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorisations, and lifecycle management activities.
• Build effective relationships and communication paths across local and functional organizations. 

Experience Required:

• Master’s degree (scientific area) OR Bachelor’s degree (scientific area) and previous directly related experience.
• Degree and in-depth regulatory experience and/or related to the region.
• Depth knowledge of regional countries legislation and regulations relating to medicinal products.
• Experience with Market Authorisations, CTAs, post approval changes and amendments, extensions, and renewals.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote reference 107533 in all correspondence.