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 or biologics

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.