Sun Pharma Hiring Regulatory Affairs
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why Join Sun Pharma
- FAQs
M.Pharm Regulatory Affairs Openings – Sun Pharma, Vadodara
Sun Pharma hiring M.Pharm professionals in Regulatory Affairs (US market) at Vadodara. Apply with 1–6 years of pharma RA experience.
Sun Pharmaceutical Industries Ltd., India’s leading multinational pharma company, is inviting applications for Regulatory Affairs (US Market) positions at its Vadodara location. This is an excellent opportunity for M.Pharm professionals with 1–6 years of relevant experience to join one of the world’s most respected and innovation-driven pharmaceutical organizations.
Company Overview
Sun Pharma is a global healthcare leader known for delivering high-quality, affordable medicines trusted by healthcare professionals and patients in over 100 countries. With more than 40 manufacturing sites worldwide and approvals from major regulatory bodies like USFDA, EMA, and TGA, Sun Pharma continues to innovate across therapeutic areas such as Oncology, Cardiology, Dermatology, and Neurology.
The company’s success is built on scientific excellence, regulatory compliance, and a strong focus on quality — making it an ideal environment for professionals seeking growth in Regulatory Affairs (RA) for international markets.
Job Role & Responsibilities
As part of the US Regulatory Affairs team, you will play a critical role in ensuring global regulatory compliance for pharmaceutical products, preparing dossiers, and supporting new product submissions.
Key Responsibilities:
- Prepare, compile, and review regulatory submissions (ANDA, NDA, PAS, Annual Reports, CBE-30, CBE-0) for the USFDA.
- Coordinate with R&D, QA, QC, Packaging Development, and Manufacturing teams for timely data collection and submission.
- Evaluate changes through Change Control systems and prepare documentation for regulatory variations.
- Maintain regulatory databases and ensure submission tracking for all US filings.
- Respond to USFDA queries and deficiency letters within defined timelines.
- Ensure regulatory documentation complies with current ICH, FDA, and eCTD guidelines.
- Review labeling components, artwork, and packaging updates as per regulatory standards.
Eligibility / Qualifications
Educational Qualification:
- M.Pharm (Pharmaceutics / Regulatory Affairs / Industrial Pharmacy)
Experience Required:
- 1–6 years of relevant experience in Regulatory Affairs, specifically handling submissions for the US Market (ANDA/NDA).
Technical Skills:
- Sound knowledge of CTD/eCTD formats, Module 1–5 preparation, and dossier compilation.
- Experience in regulatory lifecycle management for US submissions.
- Familiarity with regulatory publishing tools and submission tracking systems.
Soft Skills:
- Excellent written and verbal communication skills.
- Strong analytical and coordination abilities.
- High attention to detail and a commitment to compliance and accuracy.
Location & Salary
Work Location: Vadodara, Gujarat
Department: Regulatory Affairs – US Market
Employment Type: Full-time (On-site)
Compensation: Competitive salary commensurate with experience and qualifications, along with performance-linked incentives and standard industry benefits.
Application Process
Interested candidates meeting the eligibility criteria can share their updated resumes directly to:
Email: Rosemary.varghese@sunpharma.com
Contact HR Representatives:
- Mitul Patel
- Pranav Pandya
- Mahesh Desale
Note: Shortlisted candidates will be contacted for further evaluation. Please ensure your email subject line includes:
“Application – Regulatory Affairs (US) – Vadodara”
Why Join Sun Pharma
- Work with India’s No.1 pharmaceutical company with a global reputation for regulatory excellence.
- Opportunity to gain hands-on exposure in USFDA regulatory submissions and global compliance.
- Collaborative and innovative work culture encouraging career advancement.
- Competitive compensation with comprehensive employee benefits.
- Be part of an organization driving healthcare transformation globally.
FAQs
Q1. What is the minimum qualification required for this role?
A1. M.Pharm is the minimum qualification required, with specialization in Regulatory Affairs or Pharmaceutics preferred.
Q2. How much experience is needed?
A2. Candidates with 1–6 years of experience in Regulatory Affairs (US Market) are eligible.
Q3. Is prior USFDA exposure mandatory?
A3. Yes, candidates should have prior experience in preparing or reviewing US submissions (ANDA/NDA/PAS).
Q4. What is the work location for this position?
A4. The position is based in Vadodara, Gujarat.
Q5. How can I apply?
A5. Interested candidates should email their CVs to Rosemary.varghese@sunpharma.com.
| Company | Sun Pharmaceutical Industries Ltd. |
|---|---|
| Vacancies | Regulatory Affairs – US Market |
| Required Education | M.Pharm (Pharmaceutics / Regulatory Affairs) |
| Experience | 1–6 Years |
| Location | Vadodara, Gujarat |
To apply for this job email your details to Rosemary.varghese@sunpharma.com
