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Sun Pharmaceutical Industries Ltd., the world’s fourth-largest specialty generic pharmaceutical company and India’s No. 1 pharma company, is hosting a walk-in interview on July 13, 2025, at our facility in Tandalja, Baroda. We are hiring for Regulatory Affairs – US, Regulatory Affairs – US (Labeling), and Regulatory Affairs – Plant roles to support our mission of delivering high-quality, affordable medicines to over 100 countries. Join our USFDA-approved organization and advance your career in regulatory affairs.
Walk-In Interview Details
Date: Sunday, July 13, 2025
Time: 9:30 AM to 1:00 PM
Venue: Sun Pharmaceutical Industries Ltd., Sun Pharma Road, Tandalja, Baroda, Gujarat – 390012
Contact: Email CVs to HR.Tandalja@sunpharma.com with the subject line: APPLICATION FOR REGULATORY AFFAIRS [SPECIFY ROLE]
Note: Candidates unable to attend can email their CVs. Sun Pharma does not charge for job applications or interviews. Verify opportunities through our official website to avoid fraudulent communications.
Documents to Bring
- Updated resume
- Last 3 months’ salary slips
- Latest appointment letter
- Qualification certificates (B.Pharm, M.Pharm)
- Passport-size photograph
- Aadhaar card
Available Positions
We are recruiting for multiple roles in our Regulatory Affairs department at our Baroda and Halol facilities. All positions require experience in USFDA-regulated environments. Below are the details:
Regulatory Affairs – US (Baroda)
- Qualifications: M.Pharm
- Experience: 2–7 years
- Grade: Executive / Senior Executive
- Responsibilities:
- Compile and review dossiers for US, EU, AU, Canada, and IL markets (orals and non-orals).
- Review query responses prepared by regulatory associates.
- Manage document review for dossier compilation, query responses, and lifecycle management.
- Skills: Knowledge of USFDA, EMA, TGA, and Health Canada regulations; expertise in dossier preparation and lifecycle management.
Regulatory Affairs – US (Labeling) (Baroda)
- Qualifications: B.Pharm, M.Pharm
- Experience: 2–6 years
- Grade: Senior Officer / Executive
- Responsibilities:
- Prepare and review labeling for ANDA and/or NDA applications per USFDA regulations.
- Develop Structured Product Labeling (SPL) for drug listing in compliance with USFDA standards.
- Address labeling query responses for regulatory submissions.
- Skills: Expertise in USFDA labeling guidelines, SPL preparation, and regulatory compliance.
Regulatory Affairs – Plant (Halol)
- Qualifications: M.Pharm
- Experience: 3–9 years
- Grade: Executive / Senior Executive
- Responsibilities:
- Support new product registration, re-registration, and variation filing for emerging markets.
- Manage product lifecycle by reviewing change controls and determining variation categories.
- Coordinate with corporate regulatory and plant teams for impact analysis and variation filing.
- Skills: Familiarity with QMS (Change Control, CAPA), regulatory filings, and emerging market requirements.
Candidate Preferences
We prioritize candidates with experience in USFDA-approved regulatory environments. Strong knowledge of dossier compilation, labeling, lifecycle management, and QMS processes (Change Control, CAPA) is essential. Familiarity with USFDA, EMA, TGA, and Health Canada guidelines, as well as SAP and regulatory software, will give applicants an edge.
Why Pursue a Career in Regulatory Affairs?
Regulatory Affairs is a critical function in pharmaceuticals, ensuring compliance and market access for life-saving medicines. At Sun Pharma, you’ll work with a global leader, contributing to regulatory submissions for markets like the US, EU, AU, Canada, and IL. Our roles offer growth in dossier management, labeling, and product lifecycle management.
Why Choose Gufic Biosciences?
Gufic Biosciences is renowned for its state-of-the-art sterile injectable facilities. Our Indore plant, among the largest globally for lyophilized injectables, fosters a dynamic and innovative work environment. We prioritize quality, innovation, and employee development, making us a premier choice for pharmaceutical professionals.
How to Prepare for the Interview
Arrive between 9:30 AM and 1:00 PM with all required documents. Be prepared to discuss your experience in regulatory affairs, including dossier compilation, labeling, or plant-based regulatory activities. Highlight expertise in USFDA regulations, QMS processes, or emerging market filings. Knowledge of cGMP and regulatory software will strengthen your application.
About Sun Pharmaceutical Industries Ltd.
Founded in 1983 by Dilip Shanghvi, Sun Pharma is India’s largest and the world’s fourth-largest specialty generic pharmaceutical company, with global revenues of over US$5.8 billion. With 43 manufacturing facilities across five continents and over 3,000 R&D scientists, we deliver generics, branded generics, and specialty products in over 100 countries, covering therapeutic areas like oncology, dermatology, and ophthalmology.
Our Baroda and Halol facilities are USFDA-approved hubs for innovation and compliance. Learn more at Sun Pharma.sunpharma.comsunpharma.com
Join Our Team
Don’t miss this opportunity to join India’s No. 1 pharmaceutical company. Attend our walk-in interview on July 13, 2025, at Sun Pharma Road, Tandalja, Baroda, to explore Regulatory Affairs roles. If unable to attend, email your CV to HR.Tandalja@sunpharma.com. For more details, visit Sun Pharma Careers.sunpharma.com
Disclaimer: Sun Pharma does not seek payment from prospective candidates for employment or authorize any agency to collect fees for recruitment. Be cautious of fraudulent agencies or individuals claiming to represent Sun Pharma. Verify opportunities through our official website.