Publishing Specialist

2 weeks ago

Bengaluru, Karnataka, 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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