Sun Pharma Hiring Executive – Regulatory Affairs

Executive – Regulatory Affairs Opening at Sun Pharma, Tandalja R&D | B.Pharm/M.Pharm with 2+ Years of Experience

Explore exciting opportunities in Regulatory Affairs at Sun Pharmaceutical Industries Ltd, located in Tandalja, Vadodara. This position is ideal for B.Pharm/M.Pharm graduates with a minimum of 2 years’ experience in labeling and regulatory submissions for USFDA-regulated markets.

Advance Your Career in Regulatory Affairs with Sun Pharma – Executive Role in Vadodara

Are you passionate about regulatory compliance and pharmaceutical labeling processes? Sun Pharmaceutical Industries Ltd, India’s largest pharma company, is hiring for an Executive – Regulatory Affairs position at its R&D center in Tandalja, Vadodara.

This is a key role involving ANDA/NDA labeling submissions and USFDA regulatory compliance, ideal for professionals with hands-on experience in SPL, REMS, and labeling development.

About Sun Pharmaceutical Industries Ltd

Sun Pharma is a global leader in specialty generics and branded pharmaceuticals, serving over 100 markets worldwide. With a focus on innovation, compliance, and operational excellence, Sun offers a collaborative environment for pharmaceutical professionals.

Current Openings

Position: Executive – Regulatory Affairs

• Location: Tandalja – R&D, Vadodara, Gujarat
• Department: Regulatory Affairs – US Market
• Required Education: B.Pharm / M.Pharm
• Experience: Minimum 2 years in Regulatory Affairs / Labeling functions

Accepted Education Background & Related Courses

Eligible Qualifications:

• B.Pharm
• M.Pharm (Pharmaceutical Sciences, Regulatory Affairs, Pharmaceutics)

Relevant Courses:

• USFDA Drug Approval Process
• Labeling & Structured Product Labeling (SPL)
• ANDA/NDA Regulatory Submissions
• REMS Documentation and Implementation
• Pharmaceutical Regulatory Affairs Certification

Key Responsibilities

➡️ Prepare and review labeling for ANDA/NDA applications as per USFDA norms
➡️ Generate Structured Product Labeling (SPL) for drug listings
➡️ Handle RLD updates, REMS coordination, and cross-functional communication
➡️ Maintain final labeling and artworks using software tools
➡️ Liaise with private label distributors and internal departments to manage product launches

Desired Skills & Competencies

•  Knowledge of FDA regulations and labeling compliance
• Experience in SPL generation and REMS documentation
• Proficiency in regulatory software and artwork tracking tools
• Effective cross-functional communication and coordination
• Strong analytical and problem-solving abilities

📩 How to Apply

Click below to apply via Sun Pharma’s official careers portal:
👉 Apply Now

🗓️ Apply before the vacancy closes.

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Accelerate your regulatory career with India’s top pharma company. Apply today and be part of Sun Pharma’s global success story.