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CMC Regulatory Affairs Manager

Posted 09/09/2021
£118,560 per annum
Leicestershire
Contract


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 i.e. Module 2.3) 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 Fandi Hatib on +44(0)1727 817 600 or email fhatib@achieva.co.uk



Achieva Group Limited

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