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.
Delivery Lead • India