Remote Regulatory CMC Alliance Manager

Job ID: Available for Members

Location: Massachusetts

Compensation: To Be Discussed

Staff Reviewed: Tue, May 12, 2020

This job expires in 16 days

Job Category: Project Management, Research

Telecommute Level: 100% Telecommute

Travel Requirements: No Travel

Employment Status: Independent Contractor

Employer Type: Staffing Agency

Career Level: Experienced

Education Level: Bachelors

Job Summary

A staffing agency has a current position open for a Remote Regulatory CMC Alliance Manager.

Individual must be able to fulfill the following responsibilities:

  • Project managing the regulatory CMC activities pertaining to our Chinese partner
  • Manage and lead assigned projects, including timelines and submission planning

Applicants must meet the following qualifications:

  • Bachelor's degree in scientific/engineering discipline
  • 2+ years of experience with recent China marketing application
  • Experience working with Module 3 CTD structure and prior regulatory CMC experience
  • Ability to escalate concerns or strategize with collaborators on appropriate timing of requests
  • Direct experience gathering the CMC requirements for a Chinese regulatory filing
  • Experience working with contract manufacturing organization