Sun Pharma hiring Regulatory Affairs Executive in Baroda. Apply with B.Pharm/M.Sc/M.Pharm, 1–4 years’ regulatory filings and labeling experience.
Position: Regulatory Affairs Executive
Company: Sun Pharmaceutical Industries Ltd.
Location: Baroda, India
Qualification: B.Pharm, M.Sc, or M.Pharm
Experience: 1–4 years
Job Type: Full-Time
Mode of Application: Online Application
Verified Job ✅
Job Overview
Sun Pharmaceutical Industries Ltd., one of the world’s leading pharmaceutical companies, is inviting applications for the position of Regulatory Affairs Executive in Baroda. This role focuses on US and EU regulatory filings, labeling, structured product labeling (SPL), and product launches. It’s a perfect opportunity for candidates with experience in regulatory submissions and labeling compliance, particularly with US FDA standards. Sun Pharma Hiring for Regulatory Affairs Executive
Key Responsibilities
As a Regulatory Affairs Executive at Sun Pharma, your responsibilities will include: Sun Pharma Hiring for Regulatory Affairs Executive
- Labeling Preparation & Review: Develop and review labeling for ANDA and NDA applications as per US FDA regulations.
- Structured Product Labeling (SPL): Create and manage SPL for FDA drug listings with accuracy and compliance.
- Cross-Functional Coordination: Collaborate with R&D, QA, and marketing teams to implement updates and support product launches.
- Regulatory Submissions: Handle regulatory filings and submissions, including final labeling artwork using specialized tools.
- Third-Party Liaison: Coordinate with distributors and partners to meet labeling requirements, including REMS, when required.
Eligibility Criteria
- Education: B.Pharm, M.Sc, or M.Pharm in Pharmacy or related field.
- Experience: 1–4 years in regulatory affairs, focusing on labeling and submissions for US, EU, or other regulated markets.
- Knowledge: Strong grasp of FDA labeling standards, regulatory compliance, and product launch processes.
- Skills: Excellent organizational, communication, and coordination skills.
- Technical: Familiarity with regulatory software tools for submissions and artwork management.
- Sun Pharma Hiring for Regulatory Affairs Executive
Benefits of Joining Sun Pharma
- Career Growth: Exposure to global regulatory projects across US and EU markets.
- Collaborative Culture: Work in cross-functional, innovative teams.
- Competitive Pay: Attractive salary package with additional perks like health insurance and professional development.
- Industry Reputation: Be part of India’s top pharmaceutical brand with a global presence.
How to Apply
Interested candidates can apply online through the official Sun Pharma careers portal. Sun Pharma Hiring for Regulatory Affairs Executive
Application Deadline: October 29, 2025
Frequently Asked Questions (FAQs)
Q1: What is the primary role of a Regulatory Affairs Executive at Sun Pharma?
A: To manage labeling preparation, SPL creation, FDA-compliant submissions, and support product launches. Sun Pharma Hiring for Regulatory Affairs Executive
Q2: Is experience with US FDA regulations required?
A: Yes, candidates must have knowledge and experience with US FDA labeling standards and regulatory submissions.
