Regulatory Affairs Manager - Labeling

G&L Scientific have an immediate need for Regulatory Labelling Specialists to join our team in India!

Please only apply if you can start immediately. This role can be based in our Mumbai or Hyderabad Office

Key Responsibilities:

• Preparing and reviewing product labels, leaflets, and packaging for compliance with global regulations
• Collaborating with cross-functional teams including regulatory, medical, and commercial
• Supporting product submissions, updates, and lifecycle management activities
• Maintaining labelling documentation and change control records
• Safety signal assessments, creating and maintaining CCDS
• Experience in providing labelling support across study phases
• Supporting/leading Labelling Working committee groups/ Labelling review committee
• Performing detailed gap analysis of Product Information against regulatory reference products, to determine highest level of safety information
• Authoring updates using all relevant HA guidelines and latest templates
• Preparing variation packages
• Undertaking literature reviews
• Post-approval activities