Regulatory Affairs Manager, CMC

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.

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.

Location:

The role is based in Uxbridge and offers hybrid working.

Hourly Rate:

£45.02phr PAYE.

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.
• Ensure that 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 (eg late stage clinical trials, variations, extensions and marketing applications).
• Author and coordinate responses to questions across assigned products and countries.
• 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.

Your Background:

• 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.
• Strong knowledge of relevant legislation and regulations relating to medicinal products.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 101466 in all correspondence.