Senior Director Global Regulatory and Operations Lead

4 days ago

Cambridge, Cambridgeshire, United Kingdom EPM Scientific Full time
Job Summary

EPM Scientific is seeking a highly experienced Senior Director to lead our Global Regulatory and Operations team. As a key member of our leadership team, you will be responsible for overseeing the strategic direction and operational delivery of our Regulatory Affairs functions across multiple countries.

Key Responsibilities
  • Ensure continued compliance of our Regulatory Affairs operations across multiple countries in the EU and Canada.
  • Deliver Regulatory Affairs services across multiple countries, utilizing internal or vendor resources as needed.
  • Develop and implement strategies to meet business requirements within budget.
  • Manage the Regulatory Affairs budget and ensure effective resource allocation.
  • Lead the development and implementation of our Regulatory Systems strategy, providing a clear vision to senior management for endorsement and approval.
  • Evaluate new technologies for future enhancements and improvements, and lead plans for implementation.
  • Monitor changes in regulatory guidance and provide impact assessments and strategies to senior leaders.
  • Lead the implementation of regulatory guideline changes and ensure all systems used within Regulatory Affairs are sourced, implemented, maintained, and fit for purpose.
Requirements
  • Bachelor's degree in a life science discipline.
  • Extensive experience as a regulatory professional, with a strong background in leading Regulatory Operations teams.
  • Experience with vendor oversight and outsourcing delivery models.
  • Strong leadership and problem-solving skills, with excellent communication and interpersonal abilities.
  • Ability to engage effectively with senior leaders and stakeholders within the organization.
  • Effective collaborator with a strong customer and stakeholder focus.
  • Excellent knowledge of regulatory systems, regulatory systems direction, and systems guidelines.

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