Aurigene Pharmaceutical Services Limited, a leading biotech company and a subsidiary of Dr. Reddy’s Laboratories, is currently hiring for Senior Executive – Regulatory Affairs in Bangalore. If you are an M.Pharm graduate with expertise in Regulatory Affairs or Quality Assurance and have experience in IND/NDA filings, this could be your next career opportunity.
Job Details
- Position: Senior Executive – Regulatory Affairs
- Qualification: M.Pharm (Regulatory Affairs/Quality Assurance)
- Experience: 5+ years in regulatory submissions
- Location: Bangalore
- Last Date to Apply: 15th May 2025
- Email: gayathiri_n@aurigene.com
Job Description
As a Senior Executive – Regulatory Affairs at Aurigene, your key responsibilities will include:
✔ Preparation and submission of regulatory dossiers for New Chemical Entities (NCEs) and New Biological Entities (NBEs).
✔ Liaising with Indian regulatory authorities such as CDSCO, RCGM, Central Bureau of Narcotics, and Karnataka Drugs Control Department.
✔ Handling CT-NOC (Clinical Trial No Objection Certificate), marketing authorization applications, NOC, and test license submissions.
✔ Follow-up with regulatory agencies to ensure timely approvals.
✔ Risk assessment related to regulatory filings and compliance.
✔ Providing regulatory guidance to R&D teams during drug development.
Candidate Profile
- Education: M.Pharm in Regulatory Affairs or Quality Assurance.
- Experience: Minimum 5 years in regulatory submissions, IND/NDA filings for NCEs and NBEs.
- Skills Required:
- Strong knowledge of Indian regulatory guidelines (CDSCO, RCGM, etc.).
- Experience in dossier preparation and submission.
- Ability to coordinate with regulatory authorities for approvals.
- Good understanding of clinical trial and drug approval processes.
Why Join Aurigene?
Aurigene is a pioneer in oncology and inflammatory disease research, working on precision oncology, immune checkpoint inhibitors, and Th-17 pathway therapies. Being a part of Dr. Reddy’s Laboratories, it offers:
✅ Industry-leading research environment
✅ Career growth in regulatory affairs
✅ Exposure to global regulatory standards
How to Apply?
Interested candidates can send their updated resume to gayathiri_n@aurigene.com before 15th May 2025.
