Remote Senior Director, European Regulatory Strategy

Ladders; United States; Remote; USD 161,000 - 260,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) and pension plan participation

Flexible spending accounts for health

Vacation and leave of absence

Well-being programs

Job summary

Our client in Pharmaceuticals & Biotech is seeking a Senior Director to lead European regulatory strategy for development programs from early stages through registration. You will partner 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. Compensation: $160,500 – $259,600 annually.

Qualifications

• 12+ years of regulatory affairs experience in pharma/biotech.
• 5+ years in a regulatory leadership role with European focus.
• Advanced degree preferred (PhD/PharmD/MS/JD), small molecule focus preferred.
• Proven EMA/MHRA interactions and other health authority engagements.

Responsibilities

• Lead European regulatory strategy for development programs from early to registration.
• Develop and execute regulatory strategies across Europe, including the UK and Switzerland.
• Lead preparation and submission of MAAs and CTAs.
• Represent the organization in regulatory meetings with European authorities.
• Provide regulatory guidance to cross-functional teams and integrate requirements.
• Oversee pediatric regulatory strategy for ex-US programs.
• Ensure compliance with European and international regulatory requirements.

Skills

Regulatory leadership

EU regulatory strategy

EMA/MHRA experience

Cross-functional leadership

Pediatrics regulatory

Education

Bachelor's degree in a scientific discipline

Advanced degree (PhD/PharmD/MS/JD) preferred

Job description

Our client in Pharmaceuticals & Biotech is seeking a Senior Director to lead European regulatory strategy for development programs from early stages through registration. You will partner 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. Compensation: $160,500 – $259,600 annually.