Hetero is a global pharmaceutical organization with extensive expertise in API manufacturing and regulatory operations across international markets. The company is inviting qualified professionals for its Regulatory Affairs – API team in Hyderabad, offering an opportunity to work on global regulatory submissions, CTD documentation, lifecycle management, and API registrations.
Job Overview
| Company | Hetero |
|---|---|
| Department | Regulatory Affairs – API |
| Role | Officer / Senior Executive |
| Qualification | M.Sc / M.Pharm |
| Experience | 1–5 Years |
| Job Location | Hyderabad, Telangana |
| Interview Date | 14th August 2026 (Friday) |
| Interview Time | 9:00 AM – 4:00 PM |
Job Profile & Responsibilities
The selected candidates will be responsible for regulatory activities related to API products, including:
- Experience in API Regulatory Affairs and DMF compilation as per CTD format.
- Preparation of CTD/eCTD dossiers and regulatory submissions.
- Regulatory Life Cycle Management and DMF maintenance.
- Handling regulatory deficiencies and responding to queries.
- Exposure to regulatory requirements for US, Europe, China, Japan, Korea, WHO and other global markets.
- Experience with CTD preparation for Japan and Korea will be valuable.
- Knowledge of China registration activities will be an added advantage.
- Basic understanding of ICH Guidelines and API regulatory requirements.
- Coordination with QA, QC, Production and R&D teams for regulatory documentation and submissions.
- Strong communication and documentation skills.
- Knowledge of API manufacturing processes.
Candidate Profile
| Criteria | Details |
|---|---|
| Qualification | M.Sc / M.Pharm |
| Experience | 1–5 Years |
| Domain | API Regulatory Affairs |
| Key Expertise | DMF, CTD/eCTD, Regulatory Submissions, Lifecycle Management |
| Preferred Exposure | US, Europe, China, Japan, Korea, WHO and global markets |
Walk-In Interview Details
| Date | 14th August 2026 |
|---|---|
| Time | 9:00 AM – 4:00 PM |
| Venue | Hetero Drugs Limited, (R&D) – HRF, Balanagar, Hyderabad, Telangana – 500018 |
| Role | Regulatory Affairs – API |
Documents to Carry
Candidates should bring:
- Updated Resume
- Educational Certificates
- Latest Increment Letter
- Last 3 Months’ Pay Slips
- Last 6 Months’ Bank Statements
- Passport-size Photographs
- Aadhaar Copy
Contact
A. Sravan Reddy
Phone: +91 81210 39605
Candidates who are unable to attend the walk-in can use the QR code provided in the recruitment notice to apply online.
Recruitment Notice: Hetero states that recruitment is conducted through direct channels and advises candidates to avoid unauthorized agencies or third parties requesting payment for recruitment services.
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