Senior Director-Global Regulatory Affairs - Global Regulatory Scientist

Location: Remote – US-based candidates only, no visa sponsorship available

Compensation: $169,500 – $248,600 annually

About the role

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a life sciences environment.

Responsibilities

• Advise on execution of the global regulatory strategy ensuring scientific quality and coherence
• Oversee timely preparation and delivery of regulatory submission content in collaboration with cross-functional teams
• Lead FDA meetings, managing agency interactions and negotiation strategies
• Define scientific priorities for assigned programs, ensuring alignment with regulatory plans
• Develop product labeling strategy using regulatory expertise and competitor analysis
• Provide insights on US regulatory procedures and adapt to new guidelines
• Manage compliance with regulatory requirements for marketed products in the US

Qualifications

• Advanced scientific degree (PhD, MD, PharmD) with at least 5 years of regulatory experience, or Bachelor's with 10 years experience in regulatory affairs or drug development
• Knowledge of local and regional regulatory procedures and practices
• Awareness of evolving regulatory reform initiatives is preferred
• Demonstrated expertise in integrated drug development processes and regulatory strategies
• Exceptional communication, negotiation, and presentation skills with strong attention to detail

Benefits

• Eligibility for medical, dental, vision, and prescription drug benefits
• Participation in a company-sponsored 401(k) and pension plan
• Vacation and leave of absence benefits
• Access to well-being programs, including employee assistance and fitness benefits
• Opportunities for continuous learning and professional development