CMC Regulatory Affairs Manager
CK Group are recruiting for a CMC Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 6 months initially.
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 predominately home based, but you will need to be able to get to their offices in Uxbridge for team meetings approximately once a month.
£43.94phr PAYE or £58.19phr Umb
CMC Regulatory Affairs Manager role:
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.
Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies.
Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries.
Manage strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications).
Educated to degree level or above in life sciences or a related field.
Significant experience in Regulatory Affairs including knowledge of both biological and synthetic drug products.
Experienced in Regulatory Submissions – being able to manage expectations and what can be realistically achieved as well as independently Submitting Submissions from start to finish from a strategic perspective.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56521 in all correspondence
£0 – £43.94/hour