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Global drug and device development services

Senior Global Regulatory Scientist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A bachelor's degree in a relevant scientific discipline or healthcare-related field is required.
  • Extensive experience in regulatory affairs or regulatory science within pharmaceutical, biotechnology, or contract research organization environments is required.
  • Strong knowledge of global clinical development regulations, including FDA, EMA, and ICH, and regional requirements is required.
  • Strong scientific, analytical, and critical-thinking skills, including the ability to integrate complex data into regulatory positions, are required.
  • Excellent written and verbal communication abilities and meticulous attention to detail are required.
  • Proven experience interacting with health authorities and leading cross-functional regulatory projects is required.
  • The candidate must have the legal right to work in the country where the role is based.
  • Willingness to travel approximately 10% as required.

Responsibilities

  • Lead the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones.
  • Author and review complex regulatory documents such as clinical trial applications, briefing books, and major submission components.
  • Interpret evolving global regulations, guidelines, and precedents, and advise teams on implications for programme design and execution.
  • Provide strategic input into clinical development plans, risk management strategies, and labelling considerations.
  • Represent regulatory functions in sponsor and health authority meetings, ensuring clear, scientifically robust communication.
  • Mentor junior regulatory colleagues and contribute to internal best practices, templates, and knowledge-sharing initiatives.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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