Publishing Specialist

3 weeks ago

New Delhi, India Biocon Biologics Full time

JOB DESCRIPTIONWe 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.

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