Virtual Biosimilars Regulatory Affairs Director

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Posted: Friday, July 13, 2018

Job Category: Healthcare, Program Management, Research

Telecommute Level: 100% Telecommute

Travel Requirements: No Travel

Employment Status: Independent Contractor

Employer Type: Employer

Career Level: Senior Level

Job Summary

A clinical research organization is searching for a person to fill their position for a Virtual Biosimilars Regulatory Affairs Director.

Core Responsibilities Include:

  • Leading submission and approval of 1-2 oncology biosimilars
  • Leading health authority interactions
  • Leading timely global submission of the biosimilar dossier

Must meet the following requirements for consideration:

  • Bachelor's degree in a science related field and/or other appropriate knowledge/experience
  • Experience in helping a team prepare for a Major Health Authority interaction
  • Understanding of regional (US or EU) and/or global regulatory science
  • Experience and knowledge of the disease area
  • More than 5 years of experience or equivalent of regulatory drug development
  • Other requirements as outlined in the job description