Regulatory Affairs Associate I

Roles & Responsibilities
• Publish and dispatch major and complex eCTD submission projects for EU, US, and Canada markets
• Handle post-approval lifecycle management submissions
• Perform document-level publishing activities in line with regulatory standards
• Conduct quality control checks for submission-ready documents
• Troubleshoot document-related technical and formatting issues
• Collaborate with scientific and regulatory teams for submission planning and preparation
• Ensure compliance with ICH guidelines and eCTD/NeeS specifications
• Work on regulatory IT systems including Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, and Lorenz Validator

Qualification
• B.Pharm / M.Pharm / Master of Life Sciences

Experience
• 1–3 years of experience in Regulatory Publishing
• Experience with EU and US regulatory submissions preferred
• Exposure to eCTD structure and lifecycle management

Skills
• Strong knowledge of eCTD submission structure and ICH guidelines
• Hands-on experience with regulatory IT publishing tools
• Good understanding of submission lifecycle management
• Strong documentation and quality control skills
• Excellent written and verbal communication skills
• Ability to work in a multicultural global environment
• Strong attention to detail and adherence to timelines

About the Company
Teva Pharmaceuticals is a global biopharmaceutical company with a strong presence in generics and innovative medicines across therapeutic areas such as neuroscience and immunology. With operations worldwide, Teva is known for regulatory excellence, structured career growth, and a collaborative work culture that supports professional development and global exposure.