Senior Director, US Regulatory Strategy & Submissions (Remote)

ERAPS - Executive Regulatory Affairs Professional Search; New York (NY); Remote; USD 180,000 - 240,000; Full time

Job summary

ERAPS - Executive Regulatory Affairs Professional Search seeks a Senior Director, Regulatory Affairs to lead US regulatory strategy and execution for late-stage programs. This pivotal role partners with global leaders to shape development pathways and manage high-quality Health Authority interactions throughout lifecycle.

You will drive end-to-end submissions, balance risk with opportunity, and influence decisions in a matrixed organization while guiding a team of regulatory professionals.

Qualifications

• Master's degree in a scientific or technical field required; advanced degrees preferred.
• Minimum of 9 years of regulatory experience in pharma/biotech.
• Experience with lifecycle submissions (IND, NDA, CTA, MAA) and FDA interactions.
• Liver therapeutic area experience is preferred and highly desirable.
• Strong knowledge of clinical drug development and regulatory pathways.

Responsibilities

• Lead US regulatory strategy and execution for assigned projects.
• Shape development pathways and ensure high-quality Health Authority interactions.
• Oversee end-to-end regulatory submissions across product lifecycle.
• Coordinate with global and cross-functional teams to align submission plans.
• Represent the company with Health Authorities and industry partners.

Skills

Regulatory leadership

FDA interactions

Regulatory strategy

Cross-functional collaboration

Project management

Communication

Stakeholder management

Leadership

Strategic thinking

Education

Master's degree in science/technical discipline

PharmD/PhD preferred

Job description

ERAPS - Executive Regulatory Affairs Professional Search seeks a Senior Director, Regulatory Affairs to lead US regulatory strategy and execution for late-stage programs. This pivotal role partners with global leaders to shape development pathways and manage high-quality Health Authority interactions throughout lifecycle.

You will drive end-to-end submissions, balance risk with opportunity, and influence decisions in a matrixed organization while guiding a team of regulatory professionals.