Senior Regulatory Programme Manager

2 weeks ago

Brisbane, Queensland, Australia beBeeProgram Full time $200,000 - $250,000
Job Overview

The ideal candidate will manage the planning and execution of our lead late-stage development program, Atacicept, in alignment with Vera's Regulatory strategy and commitment to health authorities globally.

  • Develop and execute comprehensive regulatory plans, timelines, and budgets for Atacicept while ensuring Regulatory alignment with organizational objectives.
  • Act as liaison between Regulatory and other Development functions; gathering and disseminating key decisions and updates across cross-functional workstreams and activities.
  • Providing Regulatory Submission Program Management support including timeline development, issue and risk management, status reporting and meeting facilitation both generally and for specific modules.
  • Work with other program managers to integrate module timelines and deliverables into the overall Regulatory Submission plans.
  • Collaborate with Regulatory and cross-functional stakeholders to manage timeline for submission documents, including IB, DSUR, PSUR, ODD annual updates, and annual reports.
  • Support development and maintenance of the Smartsheet environment necessary to manage Regulatory filings, including creating/maintaining templates and dashboards, setting up automation and transferring existing plans.
  • Provide program management support for briefing documents and agency meetings.
  • Coordinate submission scheduling with regulatory publishing and ensure delivery of high-quality documents.
  • May support other programs.

Eligibility for an annual performance incentive bonus, new hire equity, ongoing performance-based equity, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays are available.

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