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Global drug and device development services

Regulatory Scientist

Regulatory & Quality (Life Sciences)Posted on Nov 13
Full-timeBuenos Aires, ArgentinaNo salary listed

About the Job

Requirements

  • A bachelor's degree in a relevant scientific discipline or healthcare-related field is required.
  • Experience in regulatory affairs, regulatory writing, or clinical development within the pharmaceutical, biotechnology, or contract research organization industry is required.
  • A good understanding of global regulatory frameworks and guidelines relevant to clinical development is required.
  • Strong scientific, analytical, and critical-thinking skills, including the ability to interpret complex data and regulations, are required.
  • Excellent written and verbal English communication skills and high attention to detail and accuracy are required.
  • The ability to work effectively in cross-functional teams and manage multiple regulatory activities and timelines is required.
  • The employee must have the legal right to work in the country where the role is based.

Responsibilities

  • Prepare, review, and coordinate regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions.
  • Contribute to regulatory strategy development for clinical programs, including plans for health authority interactions and submissions.
  • Interpret and apply relevant regulations, guidelines, and precedents to support compliant study design and execution.
  • Collaborate with clinical, safety, chemistry, manufacturing, and controls (CMC), and other cross-functional teams to align regulatory content and messaging.
  • Monitor changes in the regulatory environment and provide guidance on potential impacts to programs and submissions.
  • Support regulatory interactions and meetings, including preparing materials and documenting outcomes.

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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