Teva Pharma Regulatory Affairs Job Opening For Life Science, Apply Online
Regulatory Affairs Associate I
Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job Id: 54238
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The Opportunity
Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities. The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate.
How you’ll spend your day
- Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US, and Canada.
- Exposure in handling post-approval submissions publishing and transmitting quality submissions to the agency.
- Perform document level publishing activities, troubleshoot document issues, and perform quality control checks for submission-ready documents as per the agency guidance.
- Collaborate with scientific personnel for planning, preparation, publishing, and quality control checks of submissions.
- Maintain working knowledge of internal and external publishing standards.
- Basic knowledge of ICH and eCTD related specifications/guidelines governing regulatory submissions (eCTD, NeeS, paper).
Your experience and qualifications
B. Pharm/M. Pharm/ Master of Life Sciences. Total years of experience required for the role: 1-3 years (if any, preferred Regulatory Publishing experience in EU and US market).
Reports To
Manager- Regulatory Submission Management
To apply for this position, please visit the original notification.
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