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Regulatory Affairs Senior Manager

2 months ago

Cambridge, Cambridgeshire, United Kingdom Hyper Recruitment Solutions Full time
Job Overview

Hyper Recruitment Solutions is seeking a seasoned professional to fill the role of Global Regulatory & Operations Senior Director. This position is a critical component of our organization, playing a pivotal role in delivering innovative treatments to patients worldwide.

As the Global Regulatory & Operations Senior Director, you will be responsible for overseeing the Regulatory Affairs (RA) Operations, driving global regulatory initiatives, refining regulatory systems, and enhancing vendor relationships. Your strategic oversight will ensure that RA operations maintain seamless compliance across 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.