Executive - Regulatory Affairs

Roles & Responsibilities

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

Competencies:

• Understanding of various regulatory requirements for new drug development
• Presentation & Communication Skills
• Interpersonal Skills
• Proficiency in Kannada

Desired Profile :

• M. Pharm/M.Sc. with 2+ yrs of experience in submission of dossiers to Indian Regulatory agencies
• Working experience of IND and NDA filing of NCE and NBE products