Regulatory Affairs

Role & responsibilities

• Prepare and review regulatory dossiers, applications, variations, and supporting documents.
• Draft responses to queries from WHO and other health authorities under appropriate supervision.
• Perform regulatory impact assessments for change controls in e-QMS.
• Review MFRs, specifications, and supporting documents for regulatory submissions.
• Support timely submission of dossiers, variations, and regulatory responses.
• Monitor applicable regulatory guidelines, circulars, and health authority requirements and communicate relevant updates.
• Support implementation of new or revised regulatory requirements across relevant functions.
• Coordinate with cross-functional teams for new product development and product lifecycle management.
• Prepare and update dossiers for post-approval changes and regulatory variations.
• Support review of regulatory responses and ensure accuracy, consistency, and compliance.
• Contribute to monthly regulatory updates and other activities assigned by the Reporting Manager/HoD.

Preferred candidate profile

Candidates having Vaccine Experience in global markets will be Preferred.