Regulatory Affairs Associate I
About the Role
Roles & Responsibilities
• Publish and dispatch regulatory submissions (eCTD/NeeS) for US, EU, and Canada markets
• Handle post-approval and lifecycle management submissions with high quality and timeliness
• Perform document-level publishing, QC checks, and troubleshoot submission issues
• Collaborate with regulatory and scientific teams for planning and publishing activities
• Ensure compliance with ICH guidelines and agency-specific publishing requirements
• Maintain and update submissions using regulatory IT systems and tools
Qualifications
• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)
• Master’s degree in Life Sciences
Experience
• 1-3 years of experience
• Regulatory publishing exposure in US/EU markets preferred
Skills
• Knowledge of eCTD, NeeS, and regulatory submission standards
• Hands-on experience with tools like Veeva Vault, Global Insight, ISI Toolbox, Adobe Acrobat, Lorenz Validator
• Good understanding of regulatory IT systems
• Strong written and spoken English communication
• Ability to work in a global, culturally diverse environment
About the Company
Teva Pharmaceuticals is a global leader in generic medicines, operating in nearly 60 countries and providing affordable, accessible healthcare solutions. Every day, over 200 million people worldwide rely on Teva medicines, making a meaningful impact on global health through innovation, quality, and inclusivity.
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