Drug Regulatory Officer

Ligasure Healthcare

5 - 10 years

4 - 8 Lacs

kolkata

Posted:3 hours ago| Platform:

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Skills Required

dossier preparation row market

Work Mode

Work from Office

Job Type

Full Time

Job Description

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-mrinmay.d@ligasurehealthcare.com

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