Global Reg Sub Publishing Specialist

1 month ago


hyderabad, India Novartis Full time
Your responsibilities include, but are not limited to:
• Manages multiple and simultaneous global regulatory submission projects in
eCTD and non-eCTD format (e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA
AtoQ, Compliance submissions, etc.).
• Drives cross-functional teams focused on the planning, compilation and dispatch
of worldwide regulatory submissions, anticipating technical obstacles and
developing solutions.
• Provides guidance to project teams related to worldwide HA submission
structure at/requirements, submission filing strategy, eCTD document
lifecycle management and submission compilation workflows.
• Tracks timely delivery of submission components, coordinates submission
publishing activities with publishing team and organizes internal review and
approvals.
• Partners with cross functional groups across the organization and contributes to
operational activities and ongoing initiatives.
• Effectively troubleshoots technical/quality issues relating to compilation,
validation and dispatch of global submission outputs.
• Assesses publishing resource and support needs and develops/implements
solutions to create efficiencies.
• Organizes, leads and facilitates and or participates in meetings with internal and
external stakeholders (including acquisitions, partnerships and divestiture
efforts).

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