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Regulatory Operations Director

vor 1 Monat

Frankfurt am Main, Hessen, Deutschland Veeva Systems Vollzeit

The Role

This Director role requires a deep understanding of the global life sciences Regulatory Operations space, RegOps business processes, and supporting technology solutions. This role will be responsible for growing Veeva's Regulatory Information Management market share.

Key Responsibilities

  • Grow and sustain the Regulatory market for the Vault RIM applications, including Vault Registrations, Submissions, Submissions Archive, and Submissions Publishing.
  • Provide thought leadership, strategy, and direction to account teams in driving new opportunities in the Regulatory space.
  • Provide business and technology guidance to the product team in support of new or enhanced features and functionality in regulatory applications.
  • Develop strategy and messaging for customer adoption of new features and functionality for new and existing customer base.
  • Sales & Consulting.
  • Coordinate resources across the customer lifecycle from sales to delivery and beyond.
  • Present at industry conferences, leading webinars, and authoring articles for industry publications.

Requirements

  • 5+ years of experience with regulatory processes and technology for submission document authoring, submission publishing/validation/viewing, registration and commitment tracking, and regulatory document archiving.
  • 3+ years of experience consulting for the regulatory operations area of a life sciences company.
  • 3+ years of experience selling software and/or services to life sciences organizations.
  • Proven ability to innovate across business processes and technology solutions.
  • Ability to hold strategic conversations with heads of regulatory and IT regarding the regulatory applications and their use within Regulatory execution.
  • Understanding of global drug development & regulatory process.
  • Ability to travel for customer meetings and presentations.

Nice to Have

  • 2+ years of experience working for a Regulatory or content management software company in a Product, Consulting or Services function.
  • 3+ years of experience directly working with Registration Management, Submissions, Submissions Archive, and Publishing technologies.
  • Experience with regulatory data standards, such as xEVMPD and IDMP, a plus.
  • Proven track record of thought leadership through industry presentations, publications, or other mechanisms.