Sun Pharmaceutical Industries Ltd has announced a new vacancy for Executive – Regulatory Affairs (India) under its R&D Regulatory Affairs division. This is an excellent opportunity for M.Pharm graduates and Regulatory Affairs professionals looking to build a career in Indian Regulatory Affairs (IRA), dossier compilation, CDSCO submissions, and CMC documentation.
The position is based in Baroda (Tandalja – R&D) and is open to freshers as well as candidates with up to 3 years of relevant experience.
If you are aiming for a career in Regulatory Affairs India, CDSCO submissions, CT/BE permissions, and post-approval changes management, this role offers strong domain exposure.
Job Overview
- Company: Sun Pharmaceutical Industries Ltd
- Role: Executive – Regulatory Affairs (India)
- Business Unit: R&D1 Regulatory Affairs
- Location: Baroda (Tandalja – R&D)
- Qualification: M.Pharm
- Experience: Fresher or minimum 3 years
- Job Grade: G12A
Key Responsibilities – Executive Regulatory Affairs (India)
The Executive IRA will be responsible for end-to-end regulatory activities related to drug substance and drug product approvals in India.
Core Regulatory Functions:
- Evaluation of regulatory strategies for India registrations
- Review of CMC documents and coordination with cross-functional teams
- Compilation of regulatory dossiers
- Submission of applications to CDSCO-HQ and CDSCO-Zonal offices
- CT (Clinical Trial) and BE (Bioequivalence) applications
- Domestic manufacturing and marketing permissions
- Import and marketing approval in India
- Post-approval regulatory changes
- Phase IV Clinical Trial applications
- Additional site notification and approval
- BE permissions for export registration
- IPC testing dossier compilation
- Permission for examination/test/analysis (Form CT-10/12/13)
- Import permissions (Form 8, Form 11, CT-17)
- Label artwork verification and compliance checking
This role provides hands-on exposure to Indian regulatory frameworks, CDSCO portal submissions, and regulatory compliance management.
Educational Qualification
- M.Pharm (Mandatory)
This role is ideal for candidates specializing in:
- Regulatory Affairs
- Pharmaceutics
- Pharmaceutical Analysis
- Pharmaceutical Chemistry
Experience Required
- Fresher (Entry-level Regulatory Affairs)
OR - Minimum 3 years of relevant experience in Indian Regulatory Affairs
Candidates with prior exposure to CDSCO submissions, dossier preparation, and CMC review will have an added advantage.
Why Join Sun Pharma?
At Sun Pharmaceutical Industries Ltd, employees are encouraged to:
- Take ownership of regulatory projects
- Work in a structured R&D regulatory environment
- Collaborate with cross-functional global teams
- Gain exposure to India drug approval processes
- Grow within a leading pharmaceutical organization
Sun Pharma is one of India’s largest pharmaceutical companies with a strong global presence, making it a strategic employer for long-term Regulatory Affairs careers.
Salary (Expected)
Based on industry standards for Executive Regulatory Affairs – India:
- ₹3.5 LPA – ₹6.5 LPA (INR)
(Salary may vary based on experience and internal grade policies.)
Who Should Apply?
This job is suitable for:
- M.Pharm freshers seeking entry into Regulatory Affairs India
- Candidates preparing for CDSCO regulatory roles
- Professionals looking to transition into IRA from QA/QC
- Pharma regulatory executives with 1–3 years of experience
If you are targeting a long-term career in Indian Regulatory Affairs (IRA), this is a strong opportunity.
How to Apply?
