ECTD Submission Specialist

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.