Assistant Manager

Regulatory Submission Management

• Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including ASEAN, South Asia, East Asia, and the Middle East.
• Coordinate with internal stakeholders and country-specific teams to ensure timely and accurate submission of regulatory documentation.

Regulatory Review and Compliance

• Conduct thorough regulatory reviews of dossier sections, particularly Quality, to ensure alignment with ICH guidelines and country-specific requirements.
• Ensure compliance with global and local regulatory SOPs and documentation standards.

Stakeholder Coordination

• Collaborate with cross-functional teams including RA (CMC), QA, Manufacturing, Clinical Affairs, and local affiliates for successful regulatory submissions and responses.
• Liaise with external stakeholders and health authorities for timely resolution of queries and deficiency letters.

Post-Approval Change Management

• Assess regulatory impacts of post-approval changes and support the documentation and implementation of change controls.
• Lead lifecycle management activities such as renewals, variations, labeling updates, and expansion into new markets.

Inspection & Tender Support

• Prepare and maintain regulatory documentation required for GMP inspections, audits, and tender submissions.
• Provide regulatory input for labeling and artwork development to ensure compliance with local guidelines.

Regulatory Strategy & Monitoring

• Support development of regulatory strategies for new product launches and market expansions.
• Stay informed about regional regulatory changes and evolving expectations of health authorities.

Documentation & Data Management

• Maintain and update regulatory trackers, dashboards, and databases to monitor project status, submission timelines, and deliverables.