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