Regulatory Affairs Associate at Teva Pharmaceuticals | Life Sciences | Apply Now
Teva Pharmaceuticals, a global leader in generic medicines, is hiring a Regulatory Affairs Associate I for its operations in Navi Mumbai, India. This Regulatory Affairs Associate role is centered on regulatory publishing, ensuring that medical submissions meet 100% quality standards and strict agency timelines. Joining a Teva Pharmaceuticals career means working for an organization that produces many products on the World Health Organization’s Essential Medicines List and serves over 200 million people daily across nearly 60 countries.
- Job Position: Regulatory Affairs Associate I
- Location: Navi Mumbai, India, 400706
- Job ID: 64525
About the Company
Teva is the world’s leading manufacturer of generic medicines. The company is driven by a mission to make health more affordable and accessible to millions. By integrating a rich variety of nationalities and backgrounds, Teva fosters an environment where people can make a tangible difference in global healthcare.
Job Overview
The primary focus of this position is the technical preparation and dispatch of regulatory submissions to major global health authorities.
Key Responsibilities:
- eCTD Management: Publish and dispatch major and complex routine lifecycle management eCTD submission projects for the EU, US, and Canada.
- Post-Approval Submissions: Handle post-approval submission publishing and ensure high-quality transmission to regulatory agencies.
- Document Publishing & QC: Perform document-level publishing, troubleshoot technical document issues, and conduct quality control (QC) checks to ensure documents are “submission-ready” per agency guidance.
- Technical Collaboration: Partner with scientific personnel for the planning, preparation, and final publishing of dossiers.
- Standard Maintenance: Maintain up-to-date knowledge of internal and external publishing standards, including ICH and eCTD specifications (eCTD, NeeS, paper).
Experience and Qualifications
To qualify for this Regulatory Affairs Associate position, candidates must meet the following academic and professional criteria:
- Education: Master of Life Sciences.
- Experience: 1-3 years of experience in the field. Preferred experience specifically in Regulatory Publishing for the EU and US markets.
- Technical Proficiency: Awareness of industry-standard systems such as Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, and Lorenz Validator.
- Communication Skills: Strong command of spoken and written English, with a sensitivity to cultural diversity within a global organization.
- IT Literacy: A solid understanding of regulatory IT systems is essential.
Pursuing a Regulatory Affairs Associate role at Teva Pharmaceuticals offers an exceptional gateway into the specialized field of eCTD publishing and global lifecycle management. This Teva Pharmaceuticals career opportunity allows professionals with a Master of Life Sciences or Pharmacy background to manage high-stakes submissions for the US, EU, and Canadian markets. If you have a minimum of one year of experience and proficiency in tools like Veeva Vault or Global Insight, apply now to join a mission-driven team dedicated to global health accessibility.
