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 will be based in our Mumbai 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.
• Solid 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.

📌 Regulatory Affairs Manager (Mumbai)
🏢 G&L Scientific
📍 Mumbai