Regulatory Affairs Manager

3 weeks ago


Uxbridge Greater London, United Kingdom CK Group- Science, Clinical and Technical Full time

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

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.

The role is based in Uxbridge and offers hybrid working.

Hourly Rate:

£02phr PAYE.

Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more products.
Ensure that CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies.
Manage strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications).
Gather, consolidate and analyse regulatory intelligence for International Markets and support its application to product-specific activities.
Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations.
Educated to degree level or above in Life sciences or a related field.
Significant experience in CMC Regulatory Affairs across global markets.
Excellent communication skills and experience of building relationships with stakeholders.
Please quote job reference (phone number removed) in all correspondence



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