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 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