PRG Pharma - Assistant Manager - Regulatory Affairs

Title : Assistant Manager Regulatory Affairs

Location : Netaji Subhash Place, Pitampura, Delhi

Experience Required : 3- 4 Years

Department : Regulatory Affairs

Employment Type : Full-Time

About the Role :

The Assistant Manager Regulatory Affairs will be responsible for managing regulatory submissions, ensuring compliance with national and international regulatory standards, handling regulatory queries, and supporting product lifecycle management.

The ideal candidate should have strong experience with dossier preparation, regulatory documentation, and exposure to ROW, semi-regulated, and regulated markets.

Key Responsibilities :

1. Regulatory Documentation & Dossier Preparation :

• Prepare, review, and compile regulatory dossiers in CTD / eCTD / ACTD formats for ROW, semi-regulated, and regulated markets.
• Ensure timely submission of dossiers for product approvals, renewals, variations, and updates.
• Maintain high-quality documentation aligned with regulatory requirements and internal standards.

Regulatory Submissions :

Regulatory Compliance :

Regulatory Queries & Communication :

Regulatory Strategy :

Post-Market Surveillance :

Regulatory Intelligence :

Audit Preparation & Inspection Readiness :

10. Cross-Functional Collaboration :

Required Qualifications :

Technical Skills :

Soft Skills :

(ref : iimjobs.com)