Regulatory Affairs Associate I

Roles & Responsibilities
• Publish and dispatch major and complex routine/lifecycle management eCTD submissions for EU, US, and Canada markets
• Handle post-approval submission publishing and ensure timely transmission to regulatory agencies
• Perform document-level publishing activities and troubleshoot document issues
• Conduct quality control (QC) checks to ensure submission readiness as per agency guidelines
• Collaborate with scientific and regulatory personnel for planning, preparation, and publishing activities
• Maintain working knowledge of internal and external publishing standards
• Ensure 100% quality and adherence to submission timelines
• Act as primary interface with Regulatory Affairs Associates

Qualification
• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy) / Master’s in Life Sciences

Experience
• 1–3 years of experience (Regulatory Publishing experience in EU and US markets preferred)

Skills
• Basic knowledge of ICH and eCTD-related specifications (eCTD, NeeS, paper submissions)
• Hands-on experience with regulatory IT systems such as Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, and Lorenz Validator
• Understanding of lifecycle management submissions
• Strong written and spoken English communication skills
• Attention to detail and quality-focused mindset
• Ability to work in a global, culturally diverse environment

About the Company
Teva Pharmaceuticals is a leading global biopharmaceutical company with a strong generics portfolio and innovative medicines in areas such as neuroscience and immunology, committed to improving access to high-quality healthcare worldwide.