Executive Regulatory Affairs Job at Sun Pharma in Baroda for MENA markets. M.Pharm/MSc with 1–4 years experience apply now.
Introduction
A strong career opportunity is available for regulatory affairs professionals looking to work on international markets. Sun Pharmaceutical Industries Ltd. is currently hiring for the position of Executive – Regulatory Affairs at its R&D facility in Baroda (Vadodara). This role is ideal for candidates who have experience in dossier preparation, regulatory submissions, and lifecycle management. If you are aiming to build expertise in global regulatory processes, especially for MENA markets, this position offers excellent growth potential. Executive Regulatory Affairs Job at Sun Pharma
Company Overview
Sun Pharmaceutical Industries Ltd. is one of the largest pharmaceutical companies in India and a global leader in specialty generics. With a presence in over 100 countries, Sun Pharma is known for its high-quality medicines, advanced research capabilities, and strong regulatory compliance systems. The company’s R&D division plays a vital role in developing innovative and generic formulations for global markets. Employees at Sun Pharma benefit from a culture that promotes continuous learning, collaboration, and career growth. Executive Regulatory Affairs Job at Sun Pharma
Job Overview (Job Details)
| Job Title | Executive – Regulatory Affairs |
|---|---|
| Company | Sun Pharmaceutical Industries Ltd. |
| Location | Baroda (Vadodara), Gujarat |
| Department | R&D Regulatory Affairs |
| Employment Type | Full-Time |
| Experience Required | 1 to 4 Years |
| Qualification | M.Sc / M.Pharm |
| Industry | Pharmaceutical |
| Functional Area | Regulatory Affairs |
| Market Focus | MENA (Middle East & North Africa) |
| Application Mode | Online |
Job Location & Employment Type
- Work Location: Tandalja R&D, Baroda (Vadodara), Gujarat
- Employment Type: Full-time
- Work Setup: Office-based R&D regulatory environment
Open Positions / Department Details
- Department: R&D Regulatory Affairs (R&D1)
- Role: Executive
- Focus Area: Regulatory submissions and lifecycle management for MENA markets
This role involves handling regulatory activities for international markets, ensuring compliance and timely product approvals. Executive Regulatory Affairs Job at Sun Pharma
Key Roles & Responsibilities
The selected candidate will be responsible for managing regulatory submissions and supporting product lifecycle activities: Executive Regulatory Affairs Job at Sun Pharma
New Submissions & Renewals
- Prepare and review CMC (Chemistry, Manufacturing, and Controls) dossiers for new product submissions
- Evaluate development reports, scale-up reports, specifications, stability protocols, and artworks
- Ensure readiness of documentation before initiation of exhibit batches
Regulatory Approvals
- Prepare responses to regulatory queries and deficiencies
- Coordinate with internal teams to ensure timely submission of responses
- Support approval processes by ensuring completeness and accuracy of submissions
Lifecycle Management
- Manage variations and post-approval changes as per country-specific regulatory requirements
- Handle changes such as API vendor updates, test parameter changes, and manufacturing site changes
- Support product harmonization activities across markets
Regulatory Compliance
- Prepare and circulate approval packages along with product history documentation
- Maintain updated product information in centralized databases
- Assess regulatory impact of change controls and variations
- Ensure compliance with regional regulatory guidelines and internal quality standards
Executive Regulatory Affairs Job at Sun Pharma
Eligibility Criteria
Education
- M.Sc or M.Pharm from a recognized university
Experience
- 1 to 4 years of experience in Regulatory Affairs
- Experience in dossier preparation and regulatory submissions is required
- Exposure to international markets (preferably MENA) is an advantage
Skills Required
- Strong understanding of regulatory requirements and dossier compilation
- Knowledge of CMC documentation and lifecycle management
- Familiarity with global regulatory guidelines
- Good analytical and documentation skills
- Strong communication and coordination abilities
- Attention to detail and compliance-oriented approach
- Ability to work in cross-functional teams
- Time management and ability to meet submission timelines
Salary & Benefits
- Salary will be as per company norms
- Additional benefits may include:
- Career development and training programs
- Exposure to global regulatory markets
- Performance-based incentives
- Health and wellness benefits
Selection Process
The recruitment process may include:
- Application screening
- Technical interview (Regulatory Affairs concepts)
- HR discussion
- Final selection
Only shortlisted candidates will be contacted. Executive Regulatory Affairs Job at Sun Pharma
How to Apply
Interested candidates should apply through the official Sun Pharma careers portal. Ensure your resume highlights your experience in regulatory submissions and dossier preparation. Executive Regulatory Affairs Job at Sun Pharma
Important Dates
- Candidates are advised to apply early due to competitive openings
Why Apply for This Pharma Job?
This role offers a great opportunity to work in global regulatory affairs with exposure to MENA markets. Candidates will gain hands-on experience in dossier preparation, regulatory submissions, and lifecycle management. Working at Sun Pharma enhances professional growth through exposure to international regulatory standards and cross-functional collaboration. It is an ideal role for candidates aiming to build a long-term career in global regulatory affairs. Executive Regulatory Affairs Job at Sun Pharma
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Sun Pharmaceutical Industries Ltd. or any organization. We do not charge any fees for job postings or applications. Candidates are advised to verify job details from the official company website before applying. Executive Regulatory Affairs Job at Sun Pharma
Final Call-to-Action
If you have experience in regulatory affairs and want to work on international markets, apply now for this opportunity at Sun Pharma and grow your career. Executive Regulatory Affairs Job at Sun Pharma
