BPharm Job at Teva Pharmaceuticals | Apply Now for the Regulatory Affairs Associate Job
Join Teva Pharmaceuticals, one of the world’s leading manufacturers of generic medicines, as a Regulatory Affairs Associate I in Navi Mumbai, India. In this BPharm Job, you’ll play a vital part in publishing and managing high-quality regulatory submissions for global markets including the EU, US, and Canada. If you have 1–3 years of regulatory publishing experience and a degree in Pharmacy or Life Sciences, this Regulatory Affairs Job is your chance to contribute to Teva’s mission of making good health more affordable and accessible worldwide.
- Job Title: Regulatory Affairs Associate I
- Location: Navi Mumbai, India, 400706
- Job ID: 64525
About the Company
Teva Pharmaceuticals is a global leader in the production of affordable, high-quality generic medicines, helping millions of patients every day. With a presence in nearly 60 countries and products listed on the World Health Organization’s Essential Medicines List, Teva’s impact on healthcare is worldwide. The company combines innovation, science, and technology to ensure accessible health for all, while fostering diversity, inclusion, and professional growth among its 37,000+ employees.
About the BPharm Job
Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities. The focus will be on ensuring 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate.
Responsibilities of the Regulatory Affairs Job
- 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 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 and publishing.
- Maintain working knowledge of internal and external publishing standards.
- Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper).
- Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator.
Education and Experience
- B. Pharm/M. Pharm
- Total years of experience required for the role: 1-3 years (if any, preferred Regulatory Publishing experience in EU and US market).
- Command over spoken and written English.
- Sensitivity to the cultural diversity of a global organization.
- Good understanding of regulatory IT systems.
