Telecommute Biosimilar Regulatory Strategist

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Posted: Friday, November 09, 2018

This job expires in 21 days

Job Category: Healthcare, Project Management, Quality Assurance

Telecommute Level: Majority

Travel Requirements: Possible Travel

Employment Status: Temporary, Independent Contractor

Employer Type: Staffing Agency

Career Level: Experienced

Education Level: Bachelors

Job Summary

A staffing agency is seeking a Telecommute Biosimilar Regulatory Strategist.

Individual must be able to fulfill the following responsibilities:

  • Ensuring that regulatory documents are prepared accurately, completely and on-time
  • Developing regulatory post-approval filing strategies and variations for global products
  • Liaising with Global Regulatory Team to progress the submission/project support

Qualifications for this position include:

  • Minimum Bachelor’s degree in a scientific discipline
  • Minimum of 5 years of regulatory experience
  • Broad functional knowledge of pharmaceutical sciences
  • Clear understanding of drug development or manufacturing/improvement processes
  • Thorough understanding of CMC regulatory change management requirements
  • Strong knowledge in global post-approval CMC change regulations