Drug Regulatory Officer

1 week ago


Kolkata, West Bengal, India Ligasure Healthcare Full time ₹ 8,00,000 - ₹ 24,00,000 per year

Job description of Drug Regulatory Affair

Company-Ligasure Healthcare Pvt Ltd.

Location- Kolkata

Position-Drug Regulatory Affair

Key Responsibilities:

  • Develop and implement regulatory strategies for assigned products in ROW markets.
  • Provide regulatory guidance during product development, lifecycle management, and market expansion projects.
  • Interpret international regulations and communicate implications to internal stakeholders.
  • Prepare, review, and submit dossiers (CTD/eCTD or country-specific formats) for new registrations, renewals, and variations.
  • Liaise with local affiliates, agents, or distributors for country-specific requirements and submissions.
  • Track and manage submission timelines and ensure timely approvals.
  • Monitor changes in regulatory requirements across ROW markets and assess impact on existing and future products.
  • Ensure regulatory compliance of product labels, artwork, and promotional materials.
  • Support audits and inspections related to regulatory affairs.
  • Work closely with R&D, QA, Manufacturing, Supply Chain, and Commercial teams to support regulatory needs.
  • Coordinate with external consultants, local agents, and distributors for regulatory filings and follow-ups.

Qualifications & Experience:

  • Education: M.Pharm / B.Pharm (Pharmaceutics / Chemistry or related field)
  • Experience: 5-10 years of experience as DRA in formulation development / NPD in a pharmaceutical company.

Please share your resume if interested-



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