Publishing Specialist

2 days ago

New Delhi, India Biocon Biologics Full time

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.

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