AGM-GRA (Regulatory Affairs)

As a Regulatory Affairs Specialist at Kashiv India, your role will involve leading or supporting filing activities for Biosimilars, NCEs, and ANDAs in emerging markets such as Japan, Canada, ANZ. Your responsibilities will include: - Handling query responses, providing audit support, and assisting in lifecycle management of the products. - Providing regulatory support for the filing of IND/CTA to various regulatory agencies. - Ensuring the maintenance of IND/CTA by submitting protocol amendments, adding investigators, obtaining EC approvals, submitting SAE reports, and preparing quarterly/annual reports. To qualify for this position, you should meet the following criteria: - Education: Masters in biotechnology, Pharma-Regulatory Affairs, or Pharmaceutical Biotechnology. - Experience: 12-15 years in the pharmaceutical industry. - Skills: Exposure to emerging markets and regulated markets, familiarity with regulatory guidance, experience in dossier preparation, and expertise in Biosimilars and NCEs. If you are passionate about regulatory affairs and have the required qualifications and skills, we encourage you to share your resume with us at manan.hathi@kashivindia.com. Join us at Kashiv India, where we are dedicated to making a difference in the pharmaceutical industry.,