Regulatory Affairs

Bharat Biotech International; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Bharat Biotech International is seeking a regulatory affairs professional in Hyderabad to prepare and review regulatory dossiers, variations, and supporting documents. You will draft responses to WHO queries under supervision and perform impact assessments for changes in the e-QMS.

You will monitor guidelines and drive timely submissions across functions. The role involves coordinating with cross-functional teams for new product development and lifecycle management, plus updating post-approval

Qualifications

• Experience in regulatory affairs and dossier handling.
• Knowledge of WHO and health authority regulatory requirements.
• Vaccine experience in global markets preferred.
• Exposure to Indian regulatory processes and guidelines.

Responsibilities

• Prepare and review regulatory dossiers, applications, variations, and supporting documents.
• Draft responses to queries from WHO and other health authorities under 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 updates.
• Support implementation of new or revised regulatory requirements across 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 tasks assigned by Reporting Manager/HoD.

Skills

Regulatory affairs

Dossier preparation

WHO queries

e-QMS

Tools

e-QMS

Job description

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.