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