Aurigene Oncology Hiring Regulatory Affairs Senior Executive

 M.Pharm Regulatory Affairs Job Opening in Bangalore | Aurigene Oncology

Hiring for M.Pharm in Regulatory Affairs with 5+ years experience at Aurigene Oncology, Bangalore. Apply now for Senior Executive position in Regulatory Affairs.

M.Pharm Regulatory Affairs Vacancy at Aurigene Oncology – Apply Now for Bangalore Location

Aurigene Oncology Limited, a Great Place To Work-certified biopharmaceutical company focused on cancer research and therapeutics, is inviting applications from experienced professionals for the position of Senior Executive – Regulatory Affairs. If you hold an M.Pharm in Regulatory Affairs or Quality Assurance and have over 5 years of hands-on experience in dossier submissions and regulatory filings, this is your chance to be part of a mission-driven team in Bangalore.

Why Choose Aurigene Oncology?

Aurigene is a leading name in oncology innovation, providing equal opportunities and fostering a diverse workplace. As part of their commitment to R&D excellence, the Regulatory Affairs team plays a pivotal role in guiding novel cancer therapies from lab to market.

 Position Details: Senior Executive – Regulatory Affairs

 Location:

Bangalore, Karnataka

Qualification Required:

M.Pharm in Regulatory Affairs or Quality Assurance

Experience:

Minimum 5 years in:

• Regulatory Affairs submissions
• IND & NDA filings for New Chemical Entities (NCEs) and New Biological Entities (NBEs)
• Interactions with Indian regulatory agencies

Key Responsibilities

• Preparation and submission of regulatory dossiers for NCEs and NBEs.
• Represent Aurigene at regulatory authorities like CDSCO, RCGM, Central Bureau of Narcotics, and Karnataka Drugs Control Department.
• Handle submissions for CT-NOC, marketing authorizations, and test licenses.
• Proactively follow up with agencies to track approvals and meet project timelines.
• Assess and mitigate regulatory risks associated with filings.
• Offer strategic regulatory guidance to internal teams during drug development stages.

 Preferred Skills

• In-depth understanding of regulatory frameworks in both Indian and international markets (especially IND & NDA pathways).
• Strong experience in module writing and document compilation for submissions.
• Excellent communication and coordination skills.

How to Apply

If you match the profile and are passionate about driving oncology innovations forward, send your resume to:

Email: gayathiri_n@aurigene.com
Subject Line: Application for Senior Executive – Regulatory Affairs

Call to Action

Don’t miss out on this high-growth opportunity in the biopharma sector. Apply now and contribute to meaningful cancer research innovations at Aurigene Oncology, Bangalore.

Job Snapshot Table

Company Name	Current Vacancies
Aurigene Oncology Ltd.	Senior Executive – Regulatory Affairs

Required Education	Experience Required
M.Pharm – RA/QA	Minimum 5 years in RA & dossier submissions