Sun Pharma hiring Executive Regulatory Affairs in Baroda. Apply for IRA role with CDSCO, dossier preparation and regulatory submission experience.
Introduction
Regulatory Affairs professionals looking to build a strong career in Indian regulatory submissions have an excellent opportunity here. Sun Pharmaceutical Industries Ltd is hiring for the role of Executive – Regulatory Affairs (India) at its Baroda R&D location. This role focuses on dossier preparation, regulatory submissions, and compliance with CDSCO guidelines.
Company Overview
Sun Pharmaceutical Industries Ltd is one of India’s largest pharmaceutical companies with a strong global presence. Known for its innovation-driven approach and high-quality manufacturing, Sun Pharma operates across multiple therapeutic areas and regulatory markets, offering excellent career growth opportunities.
Job Location & Employment Type
- Location: Baroda (Vadodara), Gujarat, India
- Department: R&D – Regulatory Affairs
- Job Type: Full-Time
- Industry: Pharmaceutical / Regulatory Affairs
Job Overview (Job Details Table)
| Job Title | Executive – Regulatory Affairs (IRA) |
|---|---|
| Company Name | Sun Pharmaceutical Industries Ltd |
| Qualification | M.Pharm |
| Experience | Minimum 3 Years |
| Job Location | Baroda (Vadodara), Gujarat |
| Employment Type | Full-Time |
| Salary | As per company norms |
| Application Mode | Online Application |
| Department | Regulatory Affairs (India) |
| Job Grade | G12A |
Open Positions / Department Details
The position is within the India Regulatory Affairs (IRA) team, responsible for handling regulatory submissions, dossier compilation, and approvals related to drug products and substances in India.
Key Roles & Responsibilities
As an Executive in Regulatory Affairs, your responsibilities will include:
- Evaluating regulatory strategies for products intended for the Indian market
- Reviewing CMC (Chemistry, Manufacturing & Controls) and other technical documents
- Coordinating with cross-functional teams for data corrections and updates
- Preparing application cover letters and regulatory documentation
- Compiling and submitting dossiers to:
- CDSCO Headquarters and Zonal Offices
- Handling submissions for:
- Clinical Trials (CT)
- Bioequivalence (BE) studies
- Domestic manufacturing and marketing approvals
- Import and marketing authorization
- Managing IPC (In-Process Control) testing dossiers and sample submissions
- Handling post-approval changes and regulatory updates
- Managing Phase IV clinical trial applications
- Coordinating additional site approvals and notifications
- Handling permissions such as:
- CT-10 / CT-12 / CT-13 (manufacturing for analysis)
- Form 11 / CT-17 (import for testing)
- Form 8 (drug import)
- Reviewing product label artworks and ensuring regulatory compliance
Eligibility Criteria
Educational Qualification
- M.Pharm (Mandatory)
Experience Required
- Minimum 3 years of experience in Regulatory Affairs
- Experience in Indian regulatory submissions (CDSCO) is required
Skills Required
- Strong knowledge of CDSCO regulations and submission processes
- Experience in dossier preparation and compilation
- Understanding of CMC documentation
- Familiarity with clinical trial and BE submission requirements
- Strong documentation and coordination skills
- Attention to detail and regulatory compliance mindset
- Ability to work with cross-functional teams
Salary & Benefits
- Salary: As per company norms
- Opportunity to work with a leading global pharmaceutical company
- Exposure to Indian regulatory frameworks and submissions
- Career growth in Regulatory Affairs and compliance
- Supportive and growth-oriented work environment
Selection Process
The recruitment process may include:
- Application Screening
- Technical Interview (Regulatory Affairs Focus)
- HR Interview
- Final Selection
Candidates with strong CDSCO and dossier experience will be preferred.
How to Apply
Interested candidates should apply through the official Sun Pharma careers portal.
Ensure your resume highlights:
- Regulatory Affairs experience
- CDSCO submission knowledge
- Dossier preparation expertise
Important Dates
- Application Deadline: Not specified (apply as early as possible)
Why Apply for This Pharma Job?
This role is ideal for professionals aiming to grow in Regulatory Affairs:
- Work with India’s top pharmaceutical company (Sun Pharma)
- Gain hands-on experience in CDSCO submissions and approvals
- Exposure to end-to-end regulatory lifecycle
- Opportunity to handle diverse regulatory applications
- Strong long-term career growth in RA domain
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with any recruiter or company. Candidates are advised to verify all details independently before applying. We do not charge any fee for job applications.
Final Call-to-Action
If you have experience in Regulatory Affairs and want to work on Indian regulatory submissions, apply at the earliest. This opportunity at Sun Pharma can significantly strengthen your career in pharmaceutical regulatory compliance.
