Global Regulatory Strategy Lead — Drive Lifecycle

EPM Scientific; Boston (MA); Sur place; USD 180 000 - 280 000; Plein temps

Résumé du poste

EPM Scientific is seeking an experienced Global Regulatory Affairs Lead to drive worldwide regulatory strategy for a late-stage/marketed biologic across multiple indications. You will lead global regulatory planning, health authority engagement, lifecycle management activities, and a cross-functional regulatory team supporting both approved and development-stage programs.

The role requires senior leadership communication, successful cross-functional collaboration, and a strong track record in

Qualifications

• 10+ years of Regulatory Affairs experience in pharmaceutical or biotechnology organizations.
• Experience developing and executing global regulatory strategies.
• Strong knowledge of regulatory requirements across 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.

Responsabilités

• 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.

Connaissances

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Communication with authorities

Lifecycle management

Biologics knowledge

Description du poste

EPM Scientific is seeking an experienced Global Regulatory Affairs Lead to drive worldwide regulatory strategy for a late-stage/marketed biologic across multiple indications. You will lead global regulatory planning, health authority engagement, lifecycle management activities, and a cross-functional regulatory team supporting both approved and development-stage programs.

The role requires senior leadership communication, successful cross-functional collaboration, and a strong track record in