Consultant

Job description

JOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards. RESPONSIBILITIES: • Strong understanding of eCTD, NeeS, and ICH guidelines. • Familiarity with Regulatory systems and Publishing tools. • Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint. • Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) • Manage lifecycle submissions including variations, amendments, and renewals. • Perform document-level publishing, hyperlinking, bookmarking, and validation. • Conduct quality control checks to ensure submission readiness. • Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical. • Stay updated with global regulatory guidelines (ICH, FDA, EMA). • Detail-oriented with a collaborative mindset.