Senior Regulatory Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €64,863 - €107,730
Regulatory Scientist Role Overview

As a senior regulatory scientist, you will play a critical role in ensuring the compliance of our clinical trials with relevant regulations and guidelines.

Key Responsibilities:
  • Deliver country and/or regional clinical trial regulatory submissions according to study specifics, sound scientific principles, and contractual agreements.
  • Ensure timely completion of regulatory deliverables within agreed-upon timelines, maintaining accuracy and completeness of data/documents entered into applicable systems.
  • Collaborate with cross-functional teams to drive project success, leveraging advanced knowledge of ICON's SOPs/WIs, ICH, GCP, and relevant regulations.
  • Develop and implement effective translation management strategies, meeting project requirements and delivering high-quality results.
Requirements:
  • Minimum 3 years of experience in regulatory affairs, with a strong understanding of clinical trial regulations and guidelines.
  • Excellent communication and interpersonal skills, with the ability to work effectively across diverse teams and stakeholders.
  • Fluency in English, both written and spoken.
  • Ability to recognize, exemplify, and adhere to company values centered around people, clients, and performance.

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