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Parexel Logo Parexel · IT - Administration

Senior Regulatory Affairs Associate

Peru · Job Posted May 29, 2026
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Job Description

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Job Responsibility

  • Act as Local Regulatory Contact (LRC) and prepare and submit clinical trials through the REPEC Platform in Peru
  • Allocate 50% of daily time as Global Regulatory Lead for assigned global projects, providing strategic oversight and coordination
  • Prepare country-specific labels and review LATAM labels for regulatory compliance and consistency
  • Deliver verbal and written regulatory strategy communications to global sponsors, tailoring recommendations to country-specific requirements
  • Maintain and update the Trial Master File (TMF) in Veeva Vault with study documents and critical milestone dates
  • Keep project management tools current, including budget tracking and quality issue (QI) tools

Requirements

  • Minimum 5+ years of professional experience in clinical trial regulatory affairs
  • Proven experience preparing and submitting clinical trial dossiers to the Ministry of Health (MOH) in Peru, including review of Annex 05 and completion of Annex 33
  • Demonstrated experience preparing and submitting clinical trial dossiers in other LATAM countries
  • Proficiency with Veeva Vault or similar document management system
  • Advanced written and spoken English proficiency
  • Strong regulatory strategy expertise in Peru and LATAM countries
  • Excellent verbal communication skills for presenting complex regulatory strategies to international clients
  • Client-focused approach with ability to understand and anticipate sponsor needs
  • Strong critical thinking and problem-solving abilities
  • Exceptional interpersonal and intercultural communication skills
  • Demonstrated ability to learn quickly and work with autonomy
  • Results-oriented mindset with strong attention to detail
  • Excellent teamwork, collaboration, and consulting skills

Nice to have

Experience with regulatory requirements in APAC or EU regions

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