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Regulatory Affairs Specialist

Talent Groups

Education

  • Bachelor’s degree in life sciences, Regulatory Affairs, or a related discipline required.

Experience

  • 2–5 years of experience in Regulatory Affairs
  • Experience supporting electronic regulatory submissions and document preparation in a regulated environment preferred.
  • Familiarity with eCTD structure, publishing processes, and submission-ready document requirements preferred.

Required Skills and Competencies

  • Strong organizational skills and the ability to manage multiple tasks and deadlines simultaneously.
  • Excellent attention to detail and commitment to document quality and accuracy.
  • Understanding of regulatory submission processes and document lifecycle management.
  • Ability to work effectively in a cross-functional, fast-paced environment.
  • Strong written and verbal communication skills.
  • Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint. Proficiency in Veeva RIM preferred.
  • Ability to identify issues proactively and support timely resolution.
  • Demonstrated ability to maintain confidentiality and handle sensitive documentation appropriately.
Vacancy posted 6 hours ago
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