Openings in Regulatory Affairs at Aurigene - M.Pharm Apply

Aurigene is a development stage biotech company engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, and a wholly owned subsidiary of Dr. Reddy's Laboratories Ltd. Aurigene is focused on precision - oncology, oral immune checkpoint inhibitors, and the Th-17 pathway.

Post : Senior Executive - Regulatory Affairs

Job Description
• The candidate will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders.
• The candidate will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department.
• The candidate will be responsible for regulatory submission process, including CT-NOC, marketing authorization applications, NOC & test license.
• The candidate will follow up with regulatory agencies to obtain the approvals to support the regulatory timelines
• The candidate will identify and assess regulatory risks associated with product filing.
• The candidate will provide regulatory guidance to company personnel throughout the research and development process.

Candidate Profile
M.Pharm - Regulatory Affairs/Quality Assurance with 5+ yrs. experience in submission of dossiers to Indian Regulatory agencies and working experience of IND and NDA filing of NCE and NBE products

Location : Bangalore