Regulatory Affairs Officer , Iqvia Biotech

IQVIA

São Paulo, Brazil
Clinical trial regulatory documentation
Competent authority engagement
Regulatory submission platforms
Serve as Regulatory Team Lead on complex global studies, including oversight of technical writing and submission publishing

Job Summary

  • Serve as Regulatory Team Lead on complex global studies, including oversight of technical writing and submission publishing.
  • Engage directly with clients to clarify clinical trial regulatory pathways, share lessons learned, and address feedback.
  • Provide guidance and feedback to junior colleagues; support training and continuous improvement initiatives.

Matching Summary

Serve as Regulatory Team Lead on complex global studies, including oversight of technical writing and submission publishing.

Skills & Requirements

Must-have

  • clinical trial regulatory documentation
  • Competent Authority engagement
  • regulatory submission platforms
  • Microsoft Office proficiency
  • regulatory publishing tools

Nice-to-have

  • problem-solving mindset
  • adaptability in fast-changing environments
  • biotech therapy area exposure

Key Requirements

  • 3-4 years clinical trial regulatory experience
  • Bachelor's or Master's degree
  • Expertise in at least one regulatory domain
  • Experience with EU CTR, Health Canada, US FDA IND

Work Rights

Not specified

Tailored Resume

Cover Letter