Executive Director, Regulatory Strategy

We are seeking an Executive Director, Regulatory Strategy to provide strategic regulatory leadership of programs in a therapeutic area, overseeing and directing all regulatory activities across the entire product lifecycle.

Requirements

• BS/BA degree in a life science AND BS/BA degree and 17+ years relevant biopharma and/or regulatory experience including previous leadership experience
• Master's degree preferred AND 15+ years of related experience
• PhD AND 12+ years of related experience
• Broad experience and expertise directing a regulatory team in successfully navigating all regulatory strategy considerations for a diverse array of complex programs
• Ex-US CTA experience required
• Exemplary leadership skills, including proficiency in influencing across functions & levels in the organization
• Proven record of developing high-performing teams through informal mentorship and direct supervisory relationships
• Demonstrated ability to build consensus by presenting a compelling case for ideas, negotiating persuasively, and addressing disagreements constructively; a skilled diplomat
• Cultivates a workforce through hiring, promotion, and staff development that is well-aligned with current and emerging talent needs
• Possesses highly effective people management skills with the ability to mentor, motivate, and influence staff to achieve goals
• Excellent verbal and written communication skills including the ability to convey information to audiences with a wide range of sophistication
• Prior US marketing application filing experience required

Benefits

• 401k Matching
• Generous Paid Time Off
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance