Regulatory Affairs – Domestic – Pharma

Location: PAN India (Based on Business Requirement)
Experience: 4+ Years
Qualification: M.Pharm
CTC: Up to ₹15 LPA (Based on experience and interview performance)

Role Summary

Manage domestic regulatory affairs by handling product registrations, regulatory submissions, licensing, compliance, and documentation while ensuring adherence to pharmaceutical regulatory requirements.

Key Responsibilities

• Prepare and submit regulatory dossiers to FDA, DCGI, and FSSAI.
• Manage regulatory documentation and licensing activities.
• Coordinate with R&D, QC, Production, Marketing, and Legal teams.
• Review packaging artworks and ensure regulatory compliance.
• Support pharmacovigilance and safety documentation.
• Ensure compliance with Drugs & Cosmetics Act and FSSAI regulations.

Required Skills

• Strong knowledge of Drugs & Cosmetics Act, FDA, and FSSAI regulations.
• Experience in regulatory submissions and licensing.
• Good scientific writing and documentation skills.
• Strong analytical and cross-functional coordination abilities.
• Excellent communication and attention to detail.