The publication of various regulatory actions will involve the involvement of Regulatory Affairs associate II - RA publishing. The main priorities will be completing the submission on time and with 100% quality. The main point of contact for the Regulatory Affairs Associate will be this position.
Responsibilities :
Report on and send off large-scale, intricate routine/lifecycle management eCTD submission projects to the US, Canada, and the EU
Exposure to publishing, managing, and sending high-quality submissions to agencies after approval.
Carry out document-level publishing tasks, troubleshoot document problems, and verify that submission-ready papers meet quality control standards in accordance with agency directives.
Work together with scientific staff on planning, organizing, publishing, and quality assurance inspections of submissions.
Keep up-to-date understanding of both external and internal publication standards.
Working familiarity with the ICH and the regulations (eCTD, NeeS, paper) pertaining to eCTD specifications and guidelines
Technical systems such as Adobe Acrobat, ISI Toolbox, Global Insight, and Lorenz Validator must be understood.
Requirements :
B. Pharm/M. Pharm/ Master of Life Sciences.
1-3 years (if any, preferred Regulatory Publishing experience in EU and US market)
Reports To : Manager- Regulatory Submission Management
We are all in for improved health as a leading global provider of generic medications with a robust and innovative range.
For almost a century and a half, Teva Pharmaceuticals has been creating and manufacturing medications. We have a strong position in the generics market in addition to conducting extensive research and running large operations to support our expanding line of novel medications and biopharmaceutical goods.
We currently have one of the greatest product portfolios of any pharmaceutical company in the world, with almost 3,600 goods. Every day, about 200 million individuals across 60 countries receive superior medications from Teva. We continue the tradition of more than a century of discovering novel approaches to assist patients in improving their lives by investing in the research and development of cutting-edge medications, generic medications, and biosimilars.
Encouraging patients to live longer, better lives has been our goal since Teva was founded in Jerusalem in 1901. While we strive to address the most pressing healthcare issues of the future, we are proud of our modest origins and previous achievements.
Chaim Salomon, Moshe Levin, and Yitschak Elstein could not have predicted that their modest pharmaceutical company would grow to become a global leader in its field when they first met in Jerusalem more than a century ago.
Having come a long way from our modest beginnings to influencing the global generic medicine market, we are now starting a new chapter in the biopharmaceutical history. Since Teva was founded more than a century ago, a lot has happened in the healthcare industry. What hasn't changed, though, is our steadfast commitment to providing creative and approachable solutions that promote better living.