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 &

- Due Diligence

- Review regulatory documentation related to contract manufacturing organizations (CMOs).

- Support due diligence activities for licensing, contract manufacturing, and business development opportunities.

- Evaluate regulatory compliance of manufacturing sites and products.

Tender &

- Commercial Support

- Provide regulatory support for international tenders, ensuring compliance with country-specific requirements.

- Support International Business teams in regulatory documentation required for customer submissions and commercial activities.

SAP &

- Documentation Management

- Perform SAP-related regulatory activities for product master data and documentation.

- Maintain accurate regulatory records, product registrations, and document archives.

Compliance &

- Continuous Improvement

- Ensure compliance with TGA, Medsafe, ICH, WHO-GMP, and internal quality systems.

- Monitor changes in Australian and New Zealand regulatory requirements and implement necessary updates.

- Recommend process improvements to enhance regulatory efficiency and compliance.

Key Performance Indicators (KPIs)

- Timely submission of registration and re-registration dossiers

- On-time approval of regulatory submissions

- Query response turnaround time

- Successful variation approvals

- Regulatory compliance and audit readiness

- Accuracy of regulatory documentation

- Product registration lifecycle management

- Support for commercial product launches

- Internal stakeholder satisfaction

- Zero critical regulatory observations

Educational Qualification

- M.Pharm, B.Pharm, M.Sc. (Chemistry/Life Sciences), or equivalent.

- Additional certification in Regulatory Affairs is desirable.

📌 Sr. Manager:- Regulatory Affairs (Australia & New Zealand) (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka