Executive Export Regulatory Affairs

18 hours ago

Delhi, Delhi, India Hamdard Full time ₹ 12,00,000 - ₹ 36,00,000 per year

EXECUTIVE -REGULATORY AFFAIRS Export Regulatory Affairs will be responsible for managing and coordinating regulatory submissions, product registrations, and compliance activities for international markets. This role ensures that all documentation and submissions meet the regulatory standards and timelines of target export countries, while supporting business expansion in existing and new global territories.

Key Responsibilities:

  • Prepare, review, and submit dossiers for product registrations across international markets (including but not limited to the Middle East, Africa, Asia, and the EU).
  • Coordinate with internal departments Quality Assurance, R&D, Manufacturing, and Marketing to compile technical data, product specifications, and supporting documents.
  • Track and monitor submission progress, regulatory queries, approvals, and renewal schedules to maintain compliance timelines.
  • Review and update regulatory documents in line with current international requirements and regional guidelines.
  • Maintain and update regulatory databases, tracking sheets, and registration dossiers for all assigned markets.
  • Conduct regulatory intelligence and stay updated with changes in international regulatory frameworks affecting exports.
  • Support audits, inspections, and provide regulatory guidance for export operations.
  • Mentor junior team members or interns on dossier preparation and document control.

Qualifications & Experience:

  • Masters degree in Pharmacy, Life Sciences, Chemistry, or a related field.
  • Minimum 24 years of relevant experience in international or export regulatory affairs, in pharmaceuticals, herbal, or FMCG products.
  • Strong understanding of international regulatory guidelines (WHO, ASEAN, GCC, EU, NMRA, TMDA, etc.).
  • Experience in dossier compilation (CTD/ACTD format preferred).
  • Excellent communication and coordination skills with cross-functional teams.
  • High attention to detail and ability to handle multiple projects simultaneously.
  • Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).

Key Competencies:

  • Regulatory strategy and documentation management
  • Analytical and problem-solving ability
  • Cross-functional collaboration
  • Time and priority management
  • Strong organizational and record-keeping skills

Job Location: Hamdard Building, Asaf Ali Road, New Delhi 110002

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