Publisher Specialist

6 days ago


Bengaluru, Karnataka, India Biocon Biologics Limited Full time ₹ 4,00,000 - ₹ 6,00,000 per year

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.


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