Regulatory Affairs Executive Job at Aurigene Oncology, Bengaluru- Apply Now
Discover an exciting career opportunity at Aurigene Oncology Limited—a leader in oncology research and development. Join our team in Bengaluru, India, as a Regulatory Affairs Executive and contribute to innovative pharmaceutical solutions that improve the lives of cancer patients worldwide.
Job Title: Regulatory Affairs Executive
Location: Bengaluru, Karnataka, India
About the Job
Desired Profile:
- M.Pharm with 2+ years of experience in Regulatory affairs of large molecules in India & U.S markets
- Experience in submission of dossiers to Indian Regulatory agencies
- Work experience of IND and NDA filing of NCE and NBE products
Roles & Responsibilities
- Preparation and Submission: Responsible for preparing and submitting dossiers for NCEs and NBEs, presenting it to relevant stakeholders.
- Representing the Company: Represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics, and Karnataka Drugs Control Department.
- Regulatory Processes: Oversee regulatory submission processes, including CT-NOC, marketing authorization applications, NOC & test license.
- Regulatory Timelines: Follow up with regulatory agencies to obtain approvals to support regulatory timelines.
- Regulatory Risks: Identify and assess regulatory risks associated with product filing.
- Regulatory Guidance: Provide regulatory guidance to company personnel throughout the research and development process.
Keywords: Regulatory Affairs Executive, Bengaluru, India, Pharmaceutical, Oncology, Regulatory Affairs, IND, NDA, Regulatory Submission, Regulatory Affairs Executive Job at Aurigene Oncology, Bengaluru- Apply Now
