Regulatory CMC Consultant

Zoek Pin London, UK

£50 - £60 per hour

Contract (Full time)

Posted 42 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######### or email ######.uk

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