US Regulatory Lead

About the role

For our client, we are seeking a US Regulatory Lead to join the team of a leader in the Pharmaceuticals & Biotech space. This role will own local regulatory execution for assigned products while helping shape broader regulatory strategy in a highly regulated development environment. The position serves as a key link between internal stakeholders and external health authorities, ensuring local requirements are aligned with enterprise standards and product development goals. You will help guide pathways that support timely submissions, compliance, and successful product advancement across the U.S. market.

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

Responsibilities

• Align local regulatory requirements with corporate standards
• Execute regulatory strategies and manage local submissions
• Guide on mechanisms to optimize product development
• Serve as point of contact with regulatory agencies
• Contribute to global regulatory strategy for assigned products

Qualifications

• Doctorate degree, or Master's degree with 3 years of US Regulatory experience, or Bachelor's degree with 5 years, or Associate's degree with 10 years, or high school diploma with 12 years of US Regulatory experience
• Experience managing people or leading teams
• In-depth understanding of drug development
• Knowledge of US legislation and regulations for medicinal products
• Experience with regulatory submissions and interactions with FDA

Pay

$112,744 – $152,536 annually

Benefits

• Comprehensive medical, dental, and vision coverage
• Retirement and savings plan with generous contributions
• Flexible work models where possible
• Award-winning time-off plans
• Discretionary annual bonus program and stock-based incentives