Senior Director Regulatory Policy & Strategy

Senior Director, Regulatory Strategy & Policy

Position Overview

A global biopharmaceutical organization is seeking a Senior Director, Regulatory Strategy & Policy to lead U.S. regulatory policy, advocacy, and strategic FDA engagement across a diverse portfolio of biologics, pharmaceuticals, and medical devices.

This highly visible role serves as a strategic advisor to senior Regulatory Affairs leadership and partners directly with global regulatory strategy teams to shape regulatory policy positions, influence evolving FDA frameworks, and support development and lifecycle management activities across key programs.

The position sits at the intersection of regulatory policy, FDA strategy, health authority engagement, and enterprise advocacy, offering the opportunity to influence both company-wide priorities and broader industry discussions.

Key Responsibilities

• Lead U.S. regulatory policy and advocacy initiatives supporting development-stage and commercial products.
• Monitor, interpret, and communicate emerging FDA regulations, guidance documents, and legislative developments.
• Develop and implement regulatory policy strategies that align with business objectives and evolving regulatory requirements.
• Serve as a strategic FDA advisor to regulatory, development, commercial, medical, and government affairs stakeholders.
• Lead interactions with FDA, industry groups, trade associations, and external policy stakeholders.
• Develop regulatory approaches supporting product development, approvals, lifecycle management, and indication expansion activities.
• Guide preparation and regulatory strategy for major FDA interactions, including meetings, submissions, and agency communications.
• Provide regulatory intelligence and policy analysis to support executive decision-making.
• Partner with global regulatory strategy leaders to ensure alignment between U.S. and global regulatory objectives.
• Support cross-functional teams in identifying regulatory risks, opportunities, and mitigation strategies.

Qualifications

• Bachelor's degree required; advanced scientific, regulatory, legal, pharmacy, or medical degree preferred.
• 12+ years of regulatory affairs and/or regulatory policy experience.
• Deep understanding of FDA regulations, guidance development, and U.S. policymaking processes.
• Significant experience interacting with FDA and external regulatory stakeholders.
• Demonstrated success influencing regulatory policy, advocacy initiatives, or industry-wide regulatory discussions.
• Strong experience supporting regulatory strategy throughout the product lifecycle.
• Exceptional stakeholder management and executive communication skills.
• Ability to operate effectively in a highly matrixed global environment.

Preferred Background

• Regulatory policy experience within biopharmaceuticals, biologics, medical devices, or combination products.
• Dermatology, immunology, aesthetics, or specialty medicine experience preferred.
• Experience supporting both regulatory policy and product regulatory strategy.
• Prior involvement with industry associations and regulatory advocacy initiatives.
• Strong FDA strategic engagement experience.