"Sun Pharma Hiring Regulatory Affairs Executive – Baroda, India"
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| (Sun Pharma Hiring 2025) |
Sun Pharmaceutical Industries Ltd, one of the world’s largest generic and specialty pharmaceutical companies, is inviting applications for the position of Regulatory Affairs Executive at its Baroda, Gujarat facility. This is a golden opportunity for skilled professionals who aspire to build a career in regulatory submissions, labeling, and product launch compliance for global markets including the US and EU.
Job Responsibilities:-
As a Regulatory Affairs Executive at Sun Pharma, you will be responsible for:
- Labeling Preparation & Review – Drafting and reviewing labeling content for ANDA/NDA applications in compliance with US FDA guidelines.
- Structured Product Labeling (SPL) – Creating and maintaining FDA drug listings with regulatory accuracy.
- Cross-Functional Collaboration – Coordinating with R&D, QA, and marketing teams to ensure timely product launches and labeling updates.
- Regulatory Submissions – Handling regulatory filings, submission packages, and final labeling artwork using specialized tools.
- Third-Party Coordination – Managing labeling requirements with private label distributors and meeting compliance needs such as REMS (Risk Evaluation and Mitigation Strategies).
Eligibility Criteria:-
Candidates should possess the following qualifications and skills:
- Education: B.Pharm, M.Sc, or M.Pharm in Pharmacy or related disciplines.
- Experience: Prior experience in regulatory affairs, especially in labeling and submissions for regulated markets (US, EU, etc.).
- Regulatory Knowledge: Strong familiarity with US FDA labeling standards, compliance, and product launch procedures.
- Technical Skills: Proficiency in regulatory software tools for submissions and artwork management.
- Soft Skills: Excellent communication, coordination, and organizational skills.
Why Join Sun Pharma?
Working at Sun Pharma provides several professional and personal growth benefits:
- Global Exposure – Opportunities to work on US and EU regulatory projects.
- Innovative Work Environment – Cross-functional collaboration with top industry professionals.
- Attractive Salary & Benefits – Competitive package with medical benefits and training programs.
- Industry Leadership – Be part of a top Indian pharmaceutical company with a strong global presence.
Application Process:-
Interested candidates can apply online through the official Sun Pharma Careers Portal.
👉 Click Here to Apply (replace with actual career portal link)
Last Date to Apply: October 29, 2025
Applicants are encouraged to submit their resume and a cover letter detailing experience in regulatory submissions and labeling.
Frequently Asked Questions (FAQs):-
Q1: What is the primary responsibility of a Regulatory Affairs Executive at Sun Pharma?
The main responsibility is to prepare and review labeling for ANDA/NDA applications, ensure FDA-compliant submissions, and support product launches.
Q2: Is FDA regulatory experience mandatory?
Yes, candidates must have strong knowledge of US FDA regulations and prior experience in regulated markets (US/EU).
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