Posted:1 month ago|
Platform:
Work from Office
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.
Biocon Biologics Limited
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