Remote CMC Regulatory Director

Location: District of Columbia

Compensation: To Be Discussed

Staff Reviewed: Wed, Jul 14, 2021

This job expires in: 15 days

Job Category: Healthcare

Remote Level: Partially Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors, Masters, Doctorate

Job Summary

A compliance company is seeking a Remote CMC Regulatory Director.

Must be able to:

  • Provide strategic CMC regulatory guidance to all stakeholders
  • Lead on assigned projects to provide creative forward-thinking solutions
  • Ensure up to speed on current and changing CMC regulatory guidance

Qualifications for this position include:

  • Consult, present and network at meetings (internal and external) to share expertise
  • Excellent verbal and written communication skills
  • Bachelor's degree
  • 10 years hands-on proven CMC-Regulatory experience in both pharmaceutical industry and consulting
  • Significant breadth and depth of global regulatory experience
  • Strong management experience leading and mentoring Regulatory projects
  • Proven history of successful negotiations with the FDA and global health authorities

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