Regulatory Affairs Director
What's the Job?
Lead global regulatory strategies and execution for assigned oncology development programs.
Serve as the Regulatory Affairs representative on Global Project Teams and lead the Global Regulatory Sub-Team (GRST).
Drive regulatory submissions from planning through approval while ensuring high-quality deliverables.
Lead interactions with regulatory agencies including FDA and EMA.
What's Needed?
- Advanced degree required.
- 6+ years of Regulatory Affairs experience.
- 3+ years of recent Oncology Regulatory experience.
- Experience developing global regulatory strategies and leading regulatory submissions.
- Successful Health Authority interactions with FDA and/or EMA and strong matrix leadership skills.
About the Role
The ideal candidate will have strong leadership skills, excellent communication skills, and strategic thinking abilities which will align successfully in the organization.
Requirements
Must be based in the U.S.
Qualifications
Competitive hourly compensation.
Benefits
Opportunity to lead high-impact oncology regulatory programs.
Work with global cross-functional teams and regulatory leaders.
Access to comprehensive contractor benefits and professional development resources.
Pay
$119.63 - $142.06/hr
Schedule
Remote