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 current 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 [email protected]

📌 Drug Regulatory Officer (Kolkata)
🏢 Ligasure Healthcare
📍 Kolkata