Regulatory Affairs Specialist
4 weeks ago
CK Group- Science, Clinical and Technical is seeking a highly skilled Regulatory Affairs Manager to join our team on a 12-month contract basis. The successful candidate will be responsible for executing the regional regulatory strategy and regional regulatory plans, preparing supportive documentation for regulatory deliverables, and building effective relationships and communication paths across local and functional organizations.
Key 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.
Requirements:
- Master's degree (scientific area) OR Bachelor's degree (scientific area) and previous directly related experience.
- Depth knowledge of regional countries legislation and regulations relating to medicinal products.
- Experience with Market Authorisations, CTAs, post approval changes and amendments.
Company Overview:
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.
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