Are you a B.Pharm or M.Pharm fresher eager to start a career in Regulatory Affairs?
Sagent Pharmaceuticals is inviting applications for the Junior Associate – Regulatory Affairs position in Hyderabad, Telangana.
This role offers hands-on exposure to U.S. FDA regulatory processes, eCTD dossier preparation, and documentation compliance for the generic drug market. With expert mentorship, you’ll develop a strong foundation in regulatory submissions, change control, labeling compliance, and lifecycle management — making it an ideal opportunity for recent graduates looking to specialize in the pharmaceutical regulatory domain.
🔍 Job Overview
- Position: Junior Associate – Regulatory Affairs
- Company: Sagent Pharmaceuticals
- Location: Hyderabad, Telangana (On-site)
- Employment Type: Full-time
- Experience Required: Freshers
- Notice Period: Immediate Joiners Preferred
- Work Mode: On-site
🧩 Key Responsibilities
As a Junior Associate in Regulatory Affairs, you will:
- Learn fundamentals of U.S. FDA regulatory submissions and regulatory pathways.
- Support compilation and organization of administrative and CMC documentation.
- Assist in maintaining regulatory trackers, submission logs, and version control files.
- Help with document formatting, hyperlinking, QA checks, and eCTD file organization.
- Collect technical documents such as batch records, COAs, and stability summaries.
- Support labeling and packaging text reviews for regulatory compliance.
- Participate in internal team meetings and contribute to process improvement.
- Gain hands-on training in eCTD dossier structure, labeling principles, and promotional materials compliance.
🎓 Qualifications & Eligibility
To qualify for this exciting role, candidates should have:
- A B.Pharm or M.Pharm degree.
- Academic exposure to Regulatory Affairs or Pharmaceutics.
- Basic understanding of:
- Pharmaceutical regulatory frameworks.
- Drug development stages and cGMP principles.
- CTD/eCTD structure.
- Proficiency in MS Office (Word, Excel, PDF annotation).
- Excellent written English and documentation skills.
- A strong interest in US FDA regulatory practices.
No prior experience is required — comprehensive training will be provided.
💼 Benefits of Joining Sagent Pharmaceuticals
- Exposure to U.S. FDA and global regulatory practices.
- Hands-on learning in pharmaceutical documentation and compliance.
- Collaborative work environment with experienced regulatory professionals.
- Opportunity for career growth in the U.S. generics regulatory domain.
📅 Application Process
