Qualification: M.Pharm
Experience: 4 years 
CTC: Up to ₹15 LPA (Based on experience and interview performance)

Job Overview

We are looking for a skilled professional for the role of Regulatory Affairs (Domestic) to manage regulatory compliance, licensing, and documentation for pharmaceutical products. The role involves coordinating with internal departments and regulatory authorities to ensure products meet applicable regulatory requirements and standards.

The candidate should have strong knowledge of Drugs & Cosmetics Act, FDA regulations, and FSSAI guidelines, along with experience handling regulatory submissions and documentation.

Key Responsibilities

 Regulatory Licensing & Submissions

• Prepare and submit registration dossiers for regulatory approvals from authorities such as FDA, DCGI, and FSSAI.
• Ensure compliance with Drugs & Cosmetics Act and relevant regulatory schedules.
• Manage regulatory submissions through portals such as Sugam and FSSAI.

 Regulatory Documentation

• Coordinate with R&D, QC, Production, Marketing, and Legal teams to collect required technical documents.
• Maintain documentation including batch records, analytical methods, validation reports, and stability data.

 License Management

• Ensure timely renewal of drug and food licenses for the organization across different locations.
• Maintain proper records and archival of regulatory approvals and permissions.

 Packaging Compliance

• Review and approve packaging artworks, labels, cartons, and patient information leaflets.
• Ensure packaging materials comply with applicable regulatory requirements.

 Pharmacovigilance & Safety

• Support pharmacovigilance activities including PSUR preparation and safety documentation review.
• Evaluate risk-benefit aspects of products and review safety reports.

Key Skills

• Knowledge of Drugs & Cosmetics Act and FSSAI regulations
• Experience with regulatory submissions and compliance processes
• Scientific and regulatory writing skills
• Strong analytical and documentation skills
• Ability to coordinate with cross-functional teams

Why Join Us?

• Opportunity to work in pharmaceutical regulatory affairs and compliance
• Exposure to regulatory submissions, product approvals, and safety documentation
• Collaborative work environment with experienced professionals
• Career growth opportunities in the pharmaceutical industry