Job Title: Executive – Regulatory Affairs (Labeling)
Location: Tandalja – R&D, India
Company: Sun Pharmaceutical Industries Ltd
About Sun Pharmaceutical Industries Ltd
Sun Pharma is one of the largest pharmaceutical companies globally, known for its high-quality, affordable medicines. With a strong presence in over 100 countries, Sun Pharma specializes in generics, specialty drugs, and active pharmaceutical ingredients (APIs). The company is committed to innovation, compliance, and patient safety, making it a preferred employer in the pharma industry.
Job Description
Sun Pharma is hiring an Executive – Regulatory Affairs (Labeling) to join its dynamic team in Tandalja. The role involves ensuring compliance with USFDA regulations and managing labeling-related activities for ANDA/NDA submissions.
Key Responsibilities:
✔ Preparation and review of labeling for ANDA/NDA applications and responses to FDA queries.
✔ Creation of Structured Product Labeling (SPL) for drug listing as per USFDA guidelines.
✔ Timely submission and coordination of labeling updates based on FDA notifications and RLD changes.
✔ Collaboration with cross-functional teams to ensure smooth product launches.
✔ Regulatory filings, labeling artwork management, and compliance tracking.
✔ Communication with third-party vendors and private label distributors for labeling requirements.
✔ Evaluation and implementation of REMS (Risk Evaluation and Mitigation Strategies) for submissions.
Skills & Qualifications:
- Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field.
- 2-4 years of experience in Regulatory Affairs (Labeling) with knowledge of USFDA regulations.
- Proficiency in SPL (Structured Product Labeling) and regulatory submission software.
- Strong attention to detail and ability to work in a fast-paced environment.
