Drug Regulatory Affairs Manager

Job Description – Drug Regulatory Affairs Manager (Injectables Plant)

Company: Kesar Drugs Pvt. Ltd.
Location: Panchkula, Haryana
Department: Regulatory Affairs
Position: Manager – Regulatory Affairs (Injectables)

About the Company

Kesar Drugs Pvt. Ltd., a subsidiary of Farlex Pharmaceuticals Pvt. Ltd., is a leading pharmaceutical manufacturing company specializing in Injectables (Small Volume & Large Volume Parenterals). With state-of-the-art facilities and a strong focus on quality, compliance, and innovation, we are expanding our team and looking for a highly experienced Regulatory Affairs Manager to ensure smooth approval, compliance, and regulatory submissions at national and international levels.

Key Responsibilities:

• Prepare, review, and submit dossiers (CTD/ACTD) and regulatory filings for injectables to various authorities (DCGI, CDSCO, WHO, USFDA, EU, etc.).
• Ensure compliance with Drugs & Cosmetics Act, Schedule M, WHO-GMP, and international regulatory guidelines.
• Coordinate with R&D, QA, QC, Production, and Validation teams for regulatory documentation and audits.
• Handle new product registrations, license renewals, COPP, and post-approval variations.
• Liaise with regulatory authorities and external agencies for timely approvals and inspections.
• Manage and prepare documentation for plant audits, inspections (domestic & international), and regulatory queries.
• Monitor regulatory updates and communicate their impact on business operations.
• Lead and mentor the Regulatory Affairs team, ensuring compliance strategy and timely deliverables.

Desired Candidate Profile:

• Qualification: M.Pharm / M.Sc. (Pharmaceutical Sciences / Regulatory Affairs preferred).
• Experience: 8–12 years in Regulatory Affairs, with strong exposure to injectable formulations.
• In-depth knowledge of dossier preparation, CTD/ACTD formats, and global regulatory requirements.
• Proven experience in regulatory submissions to DCGI, WHO, USFDA, EU, and ROW markets.
• Excellent communication, leadership, and coordination skills.
• Ability to manage regulatory inspections and represent the company before authorities.

What We Offer:

• Work with a fast-growing pharmaceutical group with 1000+ products.
• Exposure to domestic and international regulatory frameworks.
• Competitive salary package with growth opportunities.
• Professional work culture built on quality, compliance, and innovation.

How To Apply :-

Interested candidates can share their CV's on hradmin@farlex.in or call us at 9875998082.

Job Type: Full-time

Pay: From ₹30,000.00 per month

Education:

• Master's (Required)

Experience:

• Regulatory Affairs : 5 years (Preferred)
• Drugs Regulatory : 5 years (Preferred)

Work Location: In person