Job openings in Regulatory Affairs at Aurigene -Apply before 15th May 2025

About Aurigene

Aurigene is a dynamic biotech company and a wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd. With a strong commitment to innovation, we focus on the discovery and clinical development of next-generation therapies for cancer and inflammatory diseases. Our R&D programs target precision oncology, oral immune checkpoint inhibitors, and the Th-17 pathway.

Position Opening

Job Title: Senior Executive – Regulatory Affairs

Location: Bangalore
Application Deadline: 15th May 2025

Key Responsibilities

• Prepare and compile regulatory dossiers for New Chemical Entities (NCEs) and New Biological Entities (NBEs)

• Submit applications to Indian regulatory bodies such as CDSCO, RCGM, Central Bureau of Narcotics, and the Karnataka Drugs Control Department

• Manage end-to-end regulatory submission processes, including CT-NOC, NOC, marketing authorizations, and test licenses

• Liaise with government authorities to secure timely approvals and ensure compliance with regulatory timelines

• Evaluate and mitigate regulatory risks related to product filings

• Collaborate with internal departments to provide regulatory input throughout research and development stages

Candidate Profile

• Qualification: M.Pharm in Regulatory Affairs or Quality Assurance

• Experience: Minimum 5 years of hands-on experience in regulatory submissions to Indian authorities

• Strong knowledge of IND and NDA filing processes for NCE and NBE products

• Excellent communication and stakeholder management skills

• Ability to work independently and with cross-functional teams

How to Apply

Interested candidates can email their updated resumes to:
📧 gayathiri_n@aurigene.com
Subject Line: Application for Senior Executive – Regulatory Affairs