Senior Director, Clinical Regulatory Affairs

Overview

Role involves leading clinical regulatory approval strategy and overseeing post-approval requirements.

Ideal candidate has 12-15+ years of clinical regulatory affairs experience and strong knowledge of health authority regulations.

Locations

• United States, California, Redwood City
• United States, Maryland, Rockville

Requirements

• BSc in natural or health sciences
• 12-15+ years of clinical regulatory affairs experience
• Proficiency in writing submission documents

Responsibilities

• Develop and execute global clinical regulatory strategies
• Lead program teams in regulatory submissions
• Oversee strategy and drafting of regulatory documents
• Maintain knowledge of global regulatory environment
• Support internal teams on global regulations

Benefits

• 100% medical, dental and vision coverage
• unlimited vacation
• 3-day weekend every month
• fully-paid parental leave
• tuition reimbursement
• 401k employer contribution
• annual bonus
• equity grant