Aurigene Oncology
At Aurigene Oncology, we are driven by a singular vision: Conquering Cancer. As a leading name in oncology research and development, we are proud to offer innovative therapies to patients around the world. Now, we are looking to expand our dynamic team with a critical role in Regulatory Affairs. If you are passionate about regulatory science and aspire to contribute to groundbreaking work, this opportunity is for you!
Position: Senior Executive – Regulatory Affairs
Location: Bangalore, India
Who We Are Looking For:
We seek a qualified and experienced professional with a Master of Pharmacy (M. Pharm) specializing in Regulatory Affairs or Quality Assurance, and with over five years of relevant industry experience. The ideal candidate will have a proven track record in the submission of regulatory dossiers to Indian authorities, and exposure to US regulatory frameworks is highly desirable.
Key Qualifications:
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M. Pharm in Regulatory Affairs/ Quality Assurance.
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5+ years of hands-on experience with Indian regulatory submissions.
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Experience in writing modules and filing Investigational New Drug (IND) and New Drug Applications (NDA) for New Chemical Entities (NCEs) and New Biological Entities (NBEs).
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Strong familiarity with both Indian and US regulatory processes.
Key Responsibilities:
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Preparation and Submission: Drafting and submitting comprehensive regulatory dossiers for NCEs and NBEs to relevant authorities and internal stakeholders.
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Agency Representation: Liaising with Indian regulatory bodies such as CDSCO, RCGM, Central Bureau of Narcotics, and Karnataka Drugs Control Department.
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Regulatory Process Management: Leading the regulatory submission process, including obtaining CT-NOCs, marketing authorizations, NOCs, and test licenses.
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Regulatory Follow-up: Coordinating with regulatory agencies to ensure timely approvals and compliance with regulatory timelines.
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Risk Assessment: Identifying and mitigating regulatory risks related to product development and market filings.
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Guidance and Support: Providing ongoing regulatory advice to research and development teams throughout the product lifecycle.
Why Join Aurigene?
At Aurigene, we believe that our people are our greatest strength. As part of our team, you will work in an environment committed to scientific innovation, ethical practices, and global impact. We foster a culture of diversity, equity, and inclusion, and are proud to be recognized as a Great Place to Work® Certified company.
If you are eager to make a meaningful impact in the fight against cancer, we encourage you to apply.
How to Apply:
Interested candidates may send their updated resumes to:
📧 [email protected]
Come, be a part of our mission to make a difference in millions of lives around the world!
