Assistant Manager Regulatory Management

Position Summary

The Assistant Manager – Regulatory Management will be responsible for preparing, reviewing, and submitting regulatory dossiers and applications for international markets. The role supports product registrations, renewals, variations, and regulatory compliance activities to ensure timely market access and business continuity.

Key Responsibilities

• Prepare and submit product registration, renewal, and variation applications in compliance with country-specific regulatory requirements and CTD/ACTD guidelines.
• Coordinate with cross-functional teams to obtain, review, and compile technical documentation for regulatory submissions.
• Track submission status, maintain regulatory records, and manage correspondence with health authorities.
• Review and respond to regulatory queries within defined timelines.
• Liaise with external regulatory partners and service providers to facilitate approvals and registrations.
• Monitor regulatory changes and assess their impact on assigned markets.
• Prepare periodic reports, work plans, meeting minutes, and regulatory status updates.
• Support departmental objectives and regulatory compliance initiatives.

Required Knowledge & Skills

• Understanding of pharmaceutical product testing and manufacturing processes, documentation practices, and awareness of ICH (Q1, Q2, Q3, Q6, Q8) and WHO guidelines.
• Ability to review technical documents, including BMRs, specifications, validation reports, and stability data.
• Strong written and verbal communication skills, along with effective stakeholder management, planning and organizing, problem-solving, and the ability to prioritize work.
• Practical experience in using MS Office (Word and Excel) for routine tasks and reporting.
• Master’s degree in chemistry / Applied Chemistry or Doctor of Pharmacy (Pharm-D) from an HEC-recognized university.
• 5–6 years of professional experience in the pharmaceutical industry, preferably in Regulatory Affairs, Quality Operations, Compliance, or related technical functions.