Parexel

Regulatory Affairs Associate – Labeling VAR Coordination

Parexel

full-time

Posted on:

Location Type: Remote

Location: Mexico

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About the role

  • Responsible for managing labeling ensuring compliance with regulatory requirements
  • Support marketing authorization submissions, lifecycle management, and post-approval variations requiring labeling updates
  • Prepare, review, and update product labeling according to requirements from Health authorities
  • Ensure localized labeling content complies with each country’s standards
  • Coordinate artwork development and version control with internal teams and external vendors
  • Support Marketing Authorization Applications (MAAs), renewals, and variations that involve labeling changes
  • Prepare labeling sections of the dossier per local format
  • Work closely with RA, QA, supply chain, artwork teams, and local affiliates to ensure labeling accuracy and timely updates
  • Act as liaison between global teams and local representatives
  • Build networking within the industry and maintain client relationships

Requirements

  • Initial years of experience in an industry-related environment
  • Client-focused approach to work
  • Results orientation
  • Teamwork and collaboration skills
  • Consulting skills
  • Excellent interpersonal and intercultural communication skills, both written and verbal
  • Critical thinking and problem-solving skills
  • Proficiency in local language and extensive working knowledge of the English language
  • Minimum of a bachelor’s degree in a Scientific or Technical Discipline
Benefits
  • Health insurance
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Soft Skills
client-focused approachresults orientationteamworkcollaboration skillsconsulting skillsinterpersonal communicationintercultural communicationcritical thinkingproblem-solving skillsproficiency in local language
Certifications
bachelor’s degree in a Scientific Disciplinebachelor’s degree in a Technical Discipline