Assistant Manager, Regulatory Affairs

Job Description

Key Responsibilities

1. Dossier Preparation & Submissions

• Prepare, review, and submit CTD / ACTD / country‑specific dossiers for:
  • New product registrations
  • Line extensions (strength, pack size, shelf life)
  • Variations and renewals
• Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, Pharmacovigilance, and Manufacturing teams.
• Ensure dossier compliance with WHO, ICH, and local authority guidelines.

2. Regulatory Strategy & Market Support

• Develop registration strategies for RoW markets considering country‑specific regulations.
• Support business development by providing regulatory feasibility and timelines for new markets/products.
• Assess regulatory impact for formulation/site changes.

3. Regulatory Lifecycle Management

• Manage post‑approval changes, including:
  • CMC variations
  • Labeling updates
  • Artwork changes
• Track and ensure timely renewals/re‑registrations.
• Maintain approved product documentation and regulatory databases.

4. Health Authority Interaction

• Handle deficiency letters / queries from regulatory agencies.
• Prepare responses in coordination with internal stakeholders.
• Liaise with local agents, consultants, and partners for RoW countries.

5. Compliance & Intelligence

• Monitor regulatory guideline updates for RoW markets.
• Ensure submissions comply with the latest country requirements.
• Support internal audits, regulatory inspections, and due‑diligence audits.

6. Team & Project Coordination

• Mentor junior team members and review their regulatory work.
• Track regulatory milestones and ensure alignment with project timelines.
• Participate in cross‑functional meetings for project planning and risk assessment.

Markets Typically Covered (RoW)

• LATAM: Brazil, Mexico, Colombia, Peru, Chile, Guatemala
• MENA/GCC region
• CIS: Russia, Ukraine, Kazakhstan,etc.
• ASEAN: Philippines, Vietnam, Thailand, Malaysia

Required Qualifications & Experience

• Educational Background:
  • M.Pharm / B.Pharm
• Experience:
  • 8–10 years in Pharmaceutical Regulatory Affairs

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