Senior Director, European Regulatory Strategy Lead

For our client, we are seeking a Senior Director, European Regulatory Strategy Lead to join the team of a leader in the Pharmaceuticals & Biotech space. This senior leadership role will shape and drive European regulatory strategy for development programs from early stages through registration. You will partner closely with cross-functional teams to align regulatory plans with development objectives and serve as a key external voice with European health authorities.

Location: Remote — US based candidates only, no visa sponsorship available.

Pay

$160,500 – $259,600 annually

Responsibilities

• Serve as the European Regulatory Lead for development programs, guiding them from early development to registration
• Develop and execute regulatory strategies for product registrations across Europe, including the UK and Switzerland
• Lead the preparation and submission of major regulatory filings, such as MAAs and CTAs
• Represent the organization in regulatory meetings with European health authorities
• Provide regulatory guidance to cross-functional teams and integrate regulatory considerations into development plans
• Oversee pediatric regulatory strategy and submission activities for ex-US programs
• Ensure compliance with European and international regulatory requirements

Qualifications

• Bachelor's degree in a scientific discipline with 12+ years of regulatory affairs experience in pharmaceuticals or biotechnology
• 5+ years in a regulatory leadership role with significant European experience
• Advanced degree (PhD, PharmD, MS, or JD) preferred, especially with small molecule development
• Extensive experience with EU pediatric regulatory strategy and submissions
• Proven track record of successful interactions with EMA, MHRA, and other health authorities

Benefits

• Comprehensive medical, dental, vision, and prescription drug benefits
• 401(k) and pension plan participation
• Flexible spending accounts for healthcare and dependent care
• Vacation and leave of absence benefits
• Well-being programs including employee assistance and fitness benefits