Parexel

Senior Regulatory Affairs Associate – Regulatory Affiliate

Parexel

full-time

Posted on:

Location Type: Remote

Location: India

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Job Level

Senior

About the role

  • Preparation, Organization & Coordination of Local Regulatory Documentation
  • Provide Local Input for Post-Approval Changes & Change Control
  • Support in Audits, Inspections & Regulatory Compliance

Requirements

  • 4+ years of experience in Regulatory Affairs (Pharma or Biologics)
  • Understanding of Indian regulatory requirements for pharmaceuticals
  • Experience in module preparation and lifecycle submissions
  • Ability to handle multiple projects and meet submission deadlines
  • Comfortable working in a fast-paced, compliance-driven environment
Benefits
  • Health insurance
  • Professional development
  • Paid time off
Applicant Tracking System Keywords

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

Hard Skills & Tools
Regulatory Affairsmodule preparationlifecycle submissionsregulatory documentation
Soft Skills
organizationcoordinationability to handle multiple projectsmeeting deadlinesadaptability