Executive – Regulatory Affairs at Sun Pharma, Vadodara

📢 Job Opening: Executive – Regulatory Affairs at Sun Pharma, Vadodara

Sun Pharmaceutical Industries Ltd., one of the world's leading pharmaceutical companies, is inviting applications for the role of Executive – Regulatory Affairs at its R&D center in Tandalja, Vadodara, Gujarat. This opportunity is ideal for professionals experienced in USFDA regulatory submissions, SPL preparation, and labeling management.


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🔍 Job Overview

Position Executive – Regulatory Affairs

Company Sun Pharmaceutical Industries Ltd. (Terapia)
Location Tandalja - R&D, Vadodara, Gujarat
Industry Pharmaceuticals
Department Regulatory Affairs
Experience Level Not specified
Job Type Full-time
Date Posted July 4, 2025



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📝 Job Description

Key Responsibilities:

Preparation and review of labeling for ANDA and/or NDA applications in line with USFDA regulations.

Preparation of Structured Product Labeling (SPL) for drug listing and compliance submissions.

Respond to labeling queries and coordinate FDA labeling updates or RLD changes.

Cross-functional coordination to ensure timely product launch readiness and labeling implementation.

Use software tools for labeling artwork management and regulatory submissions.

Communicate with private label distributors/third parties to gather labeling requirements.

Evaluate REMS (Risk Evaluation and Mitigation Strategies) and coordinate departmental responses.



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✅ Qualifications & Skills

Experience in regulatory submissions, SPL generation, and labeling compliance.

Familiarity with FDA regulations, ANDA/NDA filings, and REMS.

Strong coordination and documentation skills.

Exposure to labeling tools/software and communication with external stakeholders.



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🌟 About the Company

Sun Pharma is a global leader in generic and specialty pharmaceuticals with a presence in over 100 countries. The company is known for its commitment to quality, innovation, and affordability in healthcare.


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📩 How to Apply

Apply here: Application link

All the best!!✨

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