Senior Associate Regulatory Affairs
CK Group have an opportunity for a Senior Associate in Regulatory Affairs, to join a global pharmaceutical company on a 12-month contract basis.
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 £32.29 Umbrella / £24.57 PAYE.
Location:
The role is hybrid. The office team locations are Uxbridge and Cambridge, so we'd be looking for candidates in this vicinity.
Senior Associate Regulatory Affairs role:
This Regional Regulatory Affairs provides European regional regulatory leadership/expertise and execution for the development, registration, and lifecycle management of all of our client's molecules.
Responsibilities:
1. Execute the regional regulatory strategy and regional regulatory plans.
2. Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorisations, and lifecycle management activities.
3. Build effective relationships and communication paths across local and functional organizations.
Experience Required:
4. Master’s degree (scientific area) OR Bachelor’s degree (scientific area) and 2 years of directly related experience.
5. Degree and in-depth regulatory experience and/or related to the region.
6. Depth knowledge of regional countries legislation and regulations relating to medicinal products.
7. Experience with Market Authorisations.