Global Regulatory Strategy Lead
Global Regulatory Strategy Lead
About the Opportunity
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.
- International project management experience.
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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