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 and skilled Senior Director to lead our Global Regulatory and Operations team. As a key member of our leadership team, you will be responsible for overseeing and strategically directing our Regulatory Affairs operations, including global regulatory, regulatory systems, global vendors, processes, and data analytics.

Key Responsibilities

  • Regulatory Compliance: Ensure continued compliance of EPM Scientific's Regulatory Affairs across multiple countries in the EU and Canada.
  • RA Delivery: Oversee RA delivery across multiple countries, utilizing either internal or vendor resources.
  • Business Requirements: Deliver RA to meet business requirements within budget.
  • RA Budget Management: Track and maintain the RA budget.
  • RA Systems Strategy: Develop and implement a clear vision for RA systems, providing strategic direction to senior management for endorsement and approval.
  • Technology Evaluation: Evaluate new technologies for future enhancements and improvements, and lead plans for implementation.
  • Regulatory Guidance: Evaluate changes in regulatory guidance and highlight impact and strategy management to senior leaders.
  • Regulatory Guideline Implementation: Lead corresponding regulatory guideline impact implementation.
  • Vendor Oversight: Ensure all systems used within RA are sourced, implemented, maintained, and fit for purpose.

Requirements

  • Education: BSc degree in life sciences.
  • Regulatory Experience: Extensive work as a regulatory professional essential.
  • Leadership Experience: Experience of leading Regulatory Operations (RA experience in EU or Canada).
  • Vendor Oversight: Experience of vendor oversight and outsourcing delivery models.
  • Leadership Skills: Strong leadership and problem-solving skills.
  • Communication Skills: Excellent communication skills and ability to engage with senior leaders within the organization effectively.
  • Collaboration Skills: Effective collaborator and strong customer and stakeholder focus.
  • Regulatory Knowledge: Excellent knowledge of regulatory systems, regulatory systems direction, and systems guidelines.

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