ECTD Publishing Expert

Key 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.
• Minimum Qualifications and Experience
• B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
• Minimum 4 to 8 years
• Preferred Qualifications / Skills
• Proficiency in managing Regulatory eCTD Submission for all Global Markets.
• Good knowledge on eCTD Guidance and understanding validation criteria requirement.
• Strong communication and interpersonal skills.
• Experience with electronic submission (New Development Product Filings / LCM).
• Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously.
• High level of attention to detail and accuracy in document level publishing and submission compilation / validation.
• Ability to work collaboratively in a cross-functional team environment.
• Proficiency in using regulatory databases, information management systems, and other relevant software tools.
• Commitment to staying updated on regulatory changes and advancements in the field.