Assistant Manager Regulatory Management

About the role

The Assistant Manager – Regulatory Management will prepare, review, and submit regulatory dossiers for product registrations, renewals and variations in Pakistan and other international markets. The role ensures compliance with country‑specific regulations and supports timely market access.

Key responsibilities

• Prepare and submit product registration, renewal and variation applications following CTD/ACTD guidelines.
• Coordinate with cross‑functional teams to gather and compile technical documentation for 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.
• Monitor regulatory changes and assess impact on assigned markets.
• Prepare periodic reports, work plans, meeting minutes and regulatory status updates.

Required profile

• Master’s degree in Chemistry / Applied Chemistry or Doctor of Pharmacy (Pharm‑D) from an HEC‑recognized university.
• 5–6 years of experience in the pharmaceutical industry, preferably in Regulatory Affairs, Quality Operations or Compliance.
• Strong understanding of pharmaceutical regulatory processes, documentation requirements and international registration procedures.

Required skills

• Hands‑on experience preparing dossiers using CTD/ACTD formats.
• Knowledge of ICH guidelines (Q1, Q2, Q3, Q6, Q8) and product registration, renewals and variations.
• Ability to review technical documents such as BMRs, specifications, validation reports and stability data.
• Proficiency in MS Office and regulatory documentation management systems.