Regulatory Affairs - Sr. Executive | Assistant Manager

Bharat Biotech International; Telangana; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Bharat Biotech International is seeking a Regulatory Affairs professional to author and review regulatory dossiers, applications, variations, and regulatory responses, ensuring timely compliance with health authority requirements.

The role involves coordinating with cross-functional teams for new product development and lifecycle management, monitoring regulatory guidelines, and preparing monthly updates and change-control documentation. Experience with WHO submissions preferred.

Responsibilities

• Author and review regulatory dossiers, applications, variations, and regulatory responses.
• Prepare and submit responses to WHO and other health authority queries.
• Conduct regulatory impact assessments for change controls in e-QMS.
• Review MFRs, specifications, and supporting documents for regulatory submissions.
• Monitor and interpret regulatory guidelines, circulars, and health authority requirements.
• Support implementation of new or revised regulatory requirements across relevant functions.
• Coordinate with cross-functional teams for new product development and lifecycle management.
• Prepare and update dossiers for post-approval changes and variations.
• Review regulatory responses prepared by team members for accuracy and compliance.
• Prepare monthly regulatory updates and support other activities assigned by the HoD/Reporting Manager.

Job description

Role & responsibilities

1. Author and review regulatory dossiers, applications, variations, and regulatory responses.
2. Prepare and submit responses to WHO and other health authority queries.
3. Conduct regulatory impact assessments for change controls in e-QMS.
4. Review MFRs, specifications, and supporting documents for regulatory submissions.
5. Monitor and interpret regulatory guidelines, circulars, and health authority requirements.
6. Support implementation of new or revised regulatory requirements across relevant functions.
7. Coordinate with cross-functional teams for new product development and lifecycle management.
8. Prepare and update dossiers for post-approval changes and variations.
9. Review regulatory responses prepared by team members for accuracy and compliance.
10. Prepare monthly regulatory updates and support other activities assigned by the HoD/Reporting Manager.

Preferred candidate profile

Candidates having Vaccine experience will be preferred.