Executive - Regulatory Affairs

Job Description

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