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 recent or revised regulatory requirements across relevant functions.
Coordinate with cross-functional teams for recent 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.

📌 Regulatory Affairs Hyderabad
🏢 Bharat Biotech International
📍 Hyderabad