GE HealthCare · 1 day ago

Global Regulatory Lead Pharmaceutical Development

United States

Full-time

Remote

Senior Level

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Responsibilities

Lead assigned global program development regulatory strategy and co-ordinate with National Regulatory Affairs (NRA) regulatory submission readiness.

Working with NRA, ensure timely GRA input to global development programs.

For assigned programs/projects, identify regulatory opportunities, potential risks, and mitigations.

Guide, influence and motivate, internal and external stakeholders to meet GE HealthCare business and development project team objectives.

Fulfillment of RA compliance obligations.

Qualification

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Regulatory Strategy LeadershipPharmaceutical DiagnosticsClinical RegulationsNDA/BLA SubmissionsGlobal Regulatory FrameworksPreclinical KnowledgeCMC KnowledgeRisk MitigationRegulatory Compliance

Required

Proven track record of leading successful Pan European (CP, DCP, MRP), European national and US NDA/BLA licensing submissions

Proven track record of leading successful interaction with HA and relevant stakeholders.

Proven expertise with clinical related regulations/guidance as it relates to development of product submissions.

Knowledge of preclinical and CMC as it relates to development of product submissions

Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory strategy document (GRSD) delivery.

Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs.

Ability to clearly convey and exchange information with internal and external stakeholders.

Company

GE HealthCare

Glassdoor

4.2

GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892