Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.
Post : Regulatory Affairs Associate I
Job Description
• Review of CMC documents for regulatory submission and confirm compliance with regulatory requirements of the applicable market
• Co-ordinate with cross functional teams to obtain essential documentation for regulatory submissions
• Coordinate and compile high quality regulatory submissions to Europe, International markets, within stipulated timelines and accordance to the guidelines, ensuring submission documents are accurate, compliant, and high-quality.
• Handling of deficiency responses to the queries raised by Health authority
• Evaluate change controls with respect to its impact on regulatory submissions, strategize filing category, compile submissions and resolve complex issues as they raise for Europe, international markets
• Keeping up to date with ICH guidelines and requirements of various regulatory agencies
Candidate Profile
M.Pharm/B.Pharm with 2-3 years of experience in Regulatory affairs with knowledge of CMC writing, dossier compilation, evaluation of post approval changes,in depth understanding of ICH guidelines.
Additional Information
Qualification : B.Pharm, M.Pharm
Experiences : 2-3 years
Location : Goa
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th November, 2019
See All M.Sc Alerts M.Pharm Alerts Ph.D Alerts Goa Alerts
See All Other Jobs in our Database
.png)
