Sun Pharmaceutical Industries Ltd, a global leader in generic pharmaceuticals, is inviting applications for the position of Executive – Regulatory Affairs at its R&D center in Baroda. This is an exceptional opportunity for pharmacy professionals to manage life cycle management and dossiers for emerging markets like MENA and South Africa.

Job Overview

• Company: Sun Pharmaceutical Industries Ltd
• Role: Executive – Regulatory Affairs (EM RA)
• Location: Tandalja, Baroda (Vadodara)
• Experience: 1–4 Years
• Education: M.Sc / M.Pharm

Key Responsibilities

As a Regulatory Affairs Executive at Sun Pharma, your core duties will include:

• Dossier Preparation: Reviewing and preparing CMC (Chemistry, Manufacturing, and Controls) dossiers for new submissions and renewals.
• Market Scope: Handling regulatory compliance for MENA, GCC, and South Africa markets.
• Lifecycle Management: Managing variations related to API vendor changes, site changes, and ROS parameters for drug formulations.
• Query Management: Preparing responses to health authority deficiencies to ensure timely product approvals.
• Compliance: Reviewing exhibit batch documents, stability protocols, and artworks.

Qualifications & Requirements

• Education: Post-graduate degree in Pharmacy (M.Pharm) or Science (M.Sc).
• Technical Skills: Strong understanding of regulatory requirements for South Africa and Middle East markets.
• Experience: 1 to 4 years of proven experience in Regulatory Affairs (R&D/Formulations).
• Soft Skills: Self-driven, collaborative spirit, and attention to detail.

Why Join Sun Pharma?

Sun Pharma offers a “Create your own sunshine” culture, focusing on professional growth and a supportive community. Employees benefit from working in a high-tech R&D environment (G12A Grade) with opportunities for continuous learning and career advancement.

How to Apply