Global Regulatory Strategy Lead

A global specialty biopharmaceutical company focused on innovative dermatology therapies is seeking an experienced Global Regulatory Affairs Lead to drive worldwide regulatory strategy for a late-stage/marketed biologic across multiple indications. This individual will lead global regulatory planning, health authority engagement, lifecycle management activities, and a cross-functional regulatory team supporting both approved and development-stage programs.

Responsibilities

Lead global regulatory strategy and submission planning across approved and pipeline indications.

Serve as the primary regulatory contact for key health authorities, including the FDA.

Direct a global regulatory team, establishing goals, responsibilities, and communication plans.

Drive successful regulatory outcomes across the product lifecycle.

Partner with clinical, nonclinical, CMC, commercial, and project teams to align regulatory strategy with development objectives.

Identify regulatory risks and develop mitigation strategies.

Provide regulatory leadership on global project teams and communicate updates to senior leadership.

Ensure regulatory strategies are documented and executed in accordance with global requirements and timelines.

Qualifications

10+ years of Regulatory Affairs experience within pharmaceutical or biotechnology organizations.

Proven experience developing and executing global regulatory strategies.

Strong knowledge of regulatory requirements across multiple key regions, including the U.S. and Europe.

Experience serving as a primary contact with regulatory agencies.

Background supporting biologics and/or innovative therapeutics throughout development and commercialization.

Demonstrated success working cross-functionally in matrixed global organizations.

Expertise communicating regulatory risks, strategy, and outcomes to senior leadership.

Why This Role

High-visibility leadership role supporting a commercially approved biologic with additional growth opportunities.

Direct interaction with global health authorities.

Opportunity to shape regulatory strategy across multiple indications and lifecycle stages.

Significant cross-functional exposure to development, commercial, and executive leadership teams.

Join a growing global organization with a strong commitment to innovation and patient impact.

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