Role & responsibilities
Prepare, review, and maintain regulatory dossiers, applications, and variations.
Draft and submit responses to WHO and other health authorities.
Assess regulatory impacts of e-QMS change controls.
Review MFRs, specifications, and supporting submission documents.
Monitor regulatory guidelines and support implementation of recent requirements.
Coordinate with cross-functional teams on product development and lifecycle management.
Review team members regulatory responses for accuracy and compliance.
Prepare monthly regulatory updates and complete other assigned tasks.
Preferred candidate profile
Candidates having Vaccine experience will be preferred.
📌 Regulatory Affairs Sr Executive Assistant Manager Hyderabad
🏢 Bharat Biotech International
📍 Hyderabad
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