Major Purpose of the Role
The Manager/Senior Manager – Regulatory Affairs will be responsible for managing regulatory submissions, product registrations, re-registrations, variations, and lifecycle management for Australia and Current Zealand markets. The role ensures timely regulatory approvals, compliance with TGA and Medsafe requirements, effective query management, and cross-functional coordination to support uninterrupted business operations and product commercialization.
Key Responsibilities
Regulatory Submissions
Review registration and re-registration dossiers for submission to Australia and New Zealand regulatory authorities.
Ensure dossiers comply with TGA, Medsafe, and applicable international regulatory guidelines.
Review technical documentation prior to submission to ensure completeness and regulatory compliance.
Lifecycle Management
Manage product registrations, renewals, re-registrations, and lifecycle activities.
Prepare and review variation applications and supporting documentation for approved products.




Maintain an updated database of registered products and regulatory commitments for Australia and New Zealand.
Regulatory Query Management
Review and coordinate responses to deficiency letters, regulatory queries, and agency requests.
Work closely with R&D;, Quality Assurance, Quality Control, Manufacturing, and Supply Chain teams to obtain supporting data and ensure timely responses.
Cross-Functional Coordination
Coordinate with R&D;, QA, QC, Production, and International Business teams for preparation of dossiers, variations, and regulatory submissions.
Resolve regulatory issues impacting commercial supplies and customer orders.
Support product launches by ensuring timely regulatory approvals.
Technical Support
Provide technical guidance to the regulatory affairs team on dossier compilation, variation filings, and regulatory query responses.
Mentor junior team members and ensure adherence to regulatory standards and timelines.
Contract Manufacturing & Du

📌 Sr. Manager:- Regulatory Affairs (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka