Regulatory Affairs Specialist – Consultant

Added
2 days ago
Type
Contract
Salary
Salary not provided

Related skills

microsoft office regulatory affairs regulatory submissions nda plm

📋 Description

  • Review new certificate requests and forward to suppliers.
  • Compile NDA Annual Reports and submit Drug Listings to FDA.
  • Manage multiple tasks to meet deadlines and KPIs.
  • Coordinate information to submit certificate requests; track rework.
  • Oversee legalization via Consular Services, ensuring timelines and fees.
  • Deliver Product License Maintenance Portfolio on time and quality.

🎯 Requirements

  • 3+ years Regulatory experience
  • Experience submitting US Annual Reports
  • Ability to support international product approvals
  • Advanced Microsoft Office Suite skills
  • Highly efficient communicator
  • Bachelor's degree or equivalent work experience (desirable)

🎁 Benefits

  • 12-month contract with possibility of extension
  • Remote work in Mexico
  • Global CRO environment
  • Client-facing role
  • Professional development opportunities
  • Supportive team culture
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