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 office

Key Skills and Experience Required:

• Demonstrated experience in

  CMC (Chemistry, Manufacturing, and Controls)

  for

  vaccines

  , with a solid understanding of regulatory and technical requirements.
• Proven ability in

  authoring CMC dossier sections

  for

  regulatory variations

  , including preparation, review, and management of

  Health Authority queries

  .
• Skilled in

  developing and writing CMC sections of Briefing Books

  to support regulatory submissions and meetings.
• Strong capability to

  identify and assess risks

  associated with

  submission data packages

  and proactively propose mitigation strategies.
• Effectively

  escalates issues

  with potential

  business or regulatory impact

  to line management, ensuring timely resolution and strategic decision-making.