Regulatory Affairs Manager

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.