Job Description

Job Title:

Drug and Excise Regulatory Affairs Executive

Company:

Dr. Lorman's Homeopathic Associates Pvt. Ltd.

Location:

Panchkula, Haryana

Reports To:

Regulatory Affairs Manager / Senior Management

Job Summary:

Dr. Lorman's Homeopathic Associates Pvt. Ltd. is seeking a dedicated

Drug and Excise Regulatory Affairs Executive

to manage regulatory compliance and excise matters for our homeopathic product line. The role involves preparing and managing submissions to the FDA, ensuring compliance with drug laws, and handling all excise documentation and processes.

Key Responsibilities:

? Prepare and submit product dossiers, license applications, renewals, and variations to the FDA (India) with support of previous staff.
? Ensure all products comply with the Drugs and Cosmetics Act and applicable homeopathic regulations.
? Liaise directly with the FDA and other relevant government bodies for timely approvals, renewals, and issue resolution.
? Stay updated on regulatory changes, circulars, and notifications affecting homeopathic products.
? Review product packaging, labeling, and promotional material for compliance with FDA requirements.
? Support FDA inspections and audits; ensure all records and documents are audit-ready.
? Maintain detailed regulatory trackers, archives, and filing systems for product and excise documentation.

Requirements:

? Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
? 2-4 years of regulatory affairs experience, preferably in homeopathic or pharmaceutical companies.
? Good understanding of India's Drugs and Cosmetics Act and FDA regulatory requirements.
? Strong knowledge of excise documentation and reporting.
? Excellent organizational skills with attention to detail and accuracy.
? Effective communication skills to liaise with regulatory bodies and internal teams.
? Proficiency in MS Office (Word, Excel, PowerPoint).

Preferred Skills (Bonus):

? Prior experience working specifically with homeopathic products or natural remedies.
? Familiarity with FDA online portals and submission processes.
? Experience managing regulatory audits and inspections.

What We Offer:

? An opportunity to work with one of the trusted names in the homeopathic sector.
? A supportive, collaborative environment focused on quality and compliance.
? Competitive salary and benefits.

Job Type: Full-time

Pay: ?20,000.00 - ?26,000.00 per month

Benefits:

Paid sick time Paid time off
Schedule:

Day shift Weekend availability
Supplemental Pay:

Overtime pay Yearly bonus
Work Location: In person