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Introduction
If you are aiming to build a strong career in regulatory affairs within the pharmaceutical industry, this opportunity from Sun Pharmaceutical Industries Ltd offers excellent growth potential. The company is hiring for the Executive – Regulatory Affairs (India) role at its R&D center in Baroda. This position is ideal for candidates with regulatory experience who want to work on dossier preparation, submissions, and compliance processes in India.
Job Overview
| Details | Information |
|---|---|
| Job Title | Executive – Regulatory Affairs (India) |
| Company Name | Sun Pharmaceutical Industries Ltd |
| Location | Baroda (Vadodara), Gujarat |
| Employment Type | Full-Time |
| Department | R&D – Regulatory Affairs |
| Experience Required | Minimum 3 Years |
| Education | M.Pharm |
| Salary | As per company norms |
Company Overview
Sun Pharmaceutical Industries Ltd is one of India’s leading pharmaceutical companies with a strong global presence. Known for its focus on innovation, quality, and affordable healthcare, Sun Pharma operates across multiple therapeutic segments. The company promotes a growth-oriented culture where employees are encouraged to take ownership, collaborate, and continuously improve their skills.
Job Location & Employment Type
- Location: Baroda (Vadodara), Gujarat
- Employment Type: Full-Time
- Department: R&D Regulatory Affairs
This role is based at the R&D facility and requires coordination with multiple departments involved in product registration and compliance.
Open Positions / Department Details
- Role: Executive – IRA (India Regulatory Affairs)
- Business Unit: R&D1 Regulatory Affairs
- Job Grade: G12A
- Function: Regulatory Submissions and Compliance
The position focuses on handling regulatory documentation, dossier compilation, and submission processes for approvals in India.
Key Roles & Responsibilities
The Executive Regulatory Affairs Sun Pharma role involves:
- Evaluate regulatory strategies for product registration in India
- Review CMC (Chemistry, Manufacturing, and Controls) documents and ensure compliance
- Coordinate with cross-functional teams for document corrections and updates
- Prepare regulatory application cover letters and required documentation
- Compile dossiers and submit applications to regulatory authorities
- Handle submissions to CDSCO headquarters and zonal offices
- Manage approvals related to clinical trials (CT), bioequivalence (BE), and manufacturing permissions
- Work on import and marketing authorization processes in India
- Compile IPC testing dossiers and coordinate sample submissions
- Manage post-approval regulatory changes and updates
- Handle Phase IV clinical trial applications
- Process additional site approvals and notifications
- Support export registration by obtaining BE permissions
- Manage permissions for drug testing, analysis, and import under relevant forms
- Review product label artworks and coordinate necessary corrections
Eligibility Criteria
Education
- Master’s degree in Pharmacy (M.Pharm)
Experience
- Minimum 3 years of relevant experience in regulatory affairs
- Experience with Indian regulatory submissions preferred
Skills Required
- Strong understanding of Indian regulatory guidelines and CDSCO requirements
- Experience in dossier preparation and submission
- Knowledge of clinical trial and bioequivalence regulations
- Ability to coordinate with multiple departments
- Strong documentation and analytical skills
- Good communication and problem-solving abilities
Salary & Benefits
- Salary: As per company norms
Additional benefits may include:
- Career growth opportunities
- Learning and development programs
- Exposure to global regulatory practices
- Collaborative work environment
Selection Process
The recruitment process generally includes:
- Online application submission
- Resume shortlisting
- Technical interview (Regulatory Affairs focus)
- HR interview
- Final selection
How to Apply
Interested candidates can apply through the official online career portal of Sun Pharma. Ensure your resume highlights your regulatory experience, dossier handling, and submission expertise.
Important Dates
- Application Deadline: Not specified (apply as soon as possible)
Why Apply for This Job?
The Executive Regulatory Affairs Sun Pharma Jobs 2026 role offers excellent career growth for professionals in regulatory affairs. Here’s why you should consider applying:
- Work with one of India’s top pharmaceutical companies
- Gain hands-on experience in regulatory submissions and approvals
- Opportunity to work on diverse projects including CT, BE, and marketing approvals
- Enhance your expertise in Indian regulatory systems
- Build a strong foundation for long-term career growth in pharma regulatory roles
This opportunity is especially valuable for candidates looking to grow in regulatory affairs jobs in India and gain industry-recognized experience.
FAQs
1. What is the role of an Executive in Regulatory Affairs at Sun Pharma?
The role involves preparing and submitting regulatory dossiers, coordinating with teams, and ensuring compliance with Indian regulatory authorities.
2. What qualification is required for this job?
Candidates must have an M.Pharm degree.
3. Is experience mandatory for this role?
Yes, a minimum of 3 years of relevant regulatory affairs experience is required.
4. Where is the job location?
The job is based in Baroda (Vadodara), Gujarat.
5. How can I apply for this job?
You can apply online through the official Sun Pharma careers portal.
Conclusion
The Executive Regulatory Affairs Sun Pharma Jobs 2026 opportunity is ideal for professionals looking to advance in regulatory affairs. With strong exposure to Indian regulatory processes and a supportive work environment, this role can significantly boost your pharma career. Apply soon to secure your position.
Disclaimer
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