CMC Delivery Lead

G&L Scientific have an immediate need for a CMC Delivery Lead to work with one of our clients.Please only apply if you can start immediately and can accommodate EU working hours. This position can based in our Mumbai or Hyderabad officeKey Skills and Experience Required:Demonstrated experience inCMC (Chemistry, Manufacturing, and Controls)forvaccines or biologicswith a solid understanding of regulatory and technical requirements. Proven ability inauthoring CMC dossier sectionsforregulatory variations, including preparation, review, and management ofHealth Authority queries. Skilled indeveloping and writing CMC sections of Briefing Booksto support regulatory submissions and meetings. Strong capability toidentify and assess risksassociated withsubmission data packagesand proactively propose mitigation strategies. Effectivelyescalates issueswith potentialbusiness or regulatory impactto line management, ensuring timely resolution and strategic decision-making.

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