Aurigene Oncology, a leader in conquering cancer through innovative drug discovery and development, is proud to be certified as a Great Place to Work® (June 2024 – June 2025) in India.
We are seeking a skilled Senior Executive for our Regulatory Affairs team in Bangalore to support our mission of advancing novel chemical and biological entities (NCEs and NBEs). If you are passionate about regulatory compliance and eager to contribute to life-changing oncology solutions, we invite you to join our dynamic and inclusive team.
Job Details
- Role: Senior Executive – Regulatory Affairs
- Location: Bangalore, India
- Employment Type: Full-Time
Job Description
We are looking for an experienced professional to lead regulatory submissions and ensure compliance for our innovative NCE and NBE products. The ideal candidate will bring the following qualifications, experience, and skills:
Qualifications
- M. Pharm in Regulatory Affairs or Quality Assurance
Experience
- Minimum 5 years of experience in submitting dossiers to Indian regulatory agencies.
- Proven working experience in Investigational New Drug (IND) and New Drug Application (NDA) filings for NCE and NBE products.
Technical Requirements and Responsibilities
- Prepare and submit dossiers for NCEs and NBEs, presenting them to internal and external stakeholders.
- Represent Aurigene Oncology with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics, and Karnataka Drugs Control Department.
- Manage the regulatory submission process, including Clinical Trial No Objection Certificate (CT-NOC), marketing authorization applications, NOC, and test licenses.
- Follow up with regulatory agencies to secure approvals in line with project timelines.
- Identify and assess regulatory risks associated with product filings.
- Provide regulatory guidance to company personnel throughout the research and development process.
How to Apply
Interested candidates are requested to send their updated resume to gayathiri_n@aurigene.com. Please include a cover letter highlighting your relevant experience and expertise in regulatory affairs. Shortlisted candidates will be contacted for further steps in the recruitment process.
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Why Choose Aurigene Oncology?
Aurigene Oncology is committed to conquering cancer through cutting-edge research and a collaborative, inclusive work culture. Certified as a Great Place to Work®, we prioritize diversity, equal opportunities, and employee well-being.
By joining our Bangalore team, you’ll work in a supportive environment, contribute to groundbreaking oncology solutions, and have opportunities for professional growth. Be part of a mission-driven organization that values innovation and makes a meaningful impact on global healthcare.