Executive – Regulatory Affairs at Sun Pharmaceutical Industries Ltd

📢 Job Opening: Executive – Regulatory Affairs at Sun Pharmaceutical Industries Ltd

🗓️ Posted on: July 4, 2025

📍 Location: Tandalja – R&D, Vadodara, Gujarat

🏢 Company: Sun Pharmaceutical Industries Ltd

🧾 Job Description:

Sun Pharma, one of the world’s leading pharmaceutical companies, is hiring for the role of Executive – Regulatory Affairs at its Tandalja R&D facility in Vadodara. The role primarily focuses on the preparation, review, submission, and coordination of regulatory labeling documents and activities in alignment with USFDA regulations.

🔧 Key Responsibilities:

Preparation and review of labeling for ANDA and/or NDA applications, including FDA query responses.

Preparation of Structured Product Labeling (SPL) for drug listings as per USFDA norms.

Timely submission and coordination of labeling implementation based on FDA notifications or RLD (Reference Listed Drug) updates.

Cross-functional coordination to ensure on-time product launch with compliant labeling.

Regulatory submission filings and maintenance of labeling artworks using various specialized tools/software.

Liaising with third parties/private label distributors for gathering inputs and aligning on labeling requirements.

Evaluation and coordination of REMS (Risk Evaluation and Mitigation Strategy) requirements with internal teams.

🎯 Ideal Candidate:

Candidates with hands-on experience in regulatory labeling, SPL preparation, FDA submission processes, REMS coordination, and artwork management will be preferred.

🔗 How to Apply:

Interested candidates can apply directly through:

👉 Application link