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Global Regulatory Operations Director

2 months ago

Cambridge, Cambridgeshire, United Kingdom Hyper Recruitment Solutions Full time
Global Regulatory & Operations Senior Director

Hyper Recruitment Solutions is seeking a seasoned professional to lead our Regulatory Affairs (RA) Operations as a Global Regulatory & Operations Senior Director. Based in the vibrant Cambridgeshire area, this role is a cornerstone within our organization, playing a pivotal role in delivering groundbreaking treatments to patients worldwide.

As the Global Regulatory & Operations Senior Director, you will orchestrate the RA operations, steering global regulatory initiatives, refining regulatory systems, and enhancing vendor relationships. Your strategic oversight will ensure that RA operations maintain seamless compliance across the EU and Canada's diverse regulatory environments.

Key Responsibilities:

  • Lead the RA operations, ensuring compliance and efficient delivery across multiple countries.
  • Develop and implement a comprehensive RA data management strategy, fostering data-driven decision-making.
  • Manage the strategic direction of all RA systems, aligning with business goals and financial frameworks. Manage global RA vendor strategy, overseeing performance, compliance and budgetary constraints.
  • Proactively navigate regulatory changes, crafting strategies to optimize operations and mitigate risks.

Requirements:

  • A BSc degree in life sciences.
  • Extensive experience as a regulatory professional.
  • Proven experience in leading Regulatory Operations.
  • In-depth knowledge of regulatory systems, guidelines, and emerging industry trends.