Regulatory CMC Consultant

Zoek Pin London, Greater London, England

£50 - £60/hour

Contract (Full time)

Posted 32 days ago

My client, a leading CRO, is currently searching for a CMC Consultant to join their team on an initial 12 month contract basis. You will ideally have 5+ years of experience and have a strong understanding of authoring CMC and have global regulatory experience.

Required Experience & Responsibilities:

CMC (Module 3 and other relevant CMC sections . Module ) authoring regulatory experience in pre and/or post approval submissions of pharmaceuticals/ biologics/ biosimilars/consumer health / medical devices for EU, US, AU, CA, China and other global markets.
Should have worked in renowned/ acknowledged core Pharma (generic or innovator), Biologics or competitor type/CRO companies in India.
Responsible for CMC strategy making and recommending the appropriate regulatory reporting mechanism.
Provide regulatory CMC expertise on cross-functional project teams working with suppliers and contract manufacturers as required in order to ensure alignment of development and implementation of activities with overall regulatory CMC strategies.
Manage regulatory CMC aspects of post approval change controls, liaising with stakeholders to ensure regulatory compliance.
For further details, please contact Tim Barratt on (phone number removed) or email (url removed)

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