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G&L Scientific

7 months ago

Regulatory Affairs Manager

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Company information

Company
G&L Scientific
Location
India, Maharashtra, Mumbai India
Posted
7 months ago
View all jobs at G&L Scientific

Job description

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 be 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 submissions. Strong understanding of EU regulations and guidelines such as ICH Q7, Annex 1, and Annex 11. Experience working with pharmaceutical companies, contract manufacturers, or CMOs is highly desirable. Ability to work independently and manage multiple projects simultaneously. Excellent communication and interpersonal skills are essential. Fluency in English is required.

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