Global Oncology Regulatory Strategy Director

GlaxoSmithKline; Waltham (MA); Híbrido; USD 172.000 - 286.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health care

Retirement benefits

Paid holidays

Vacation

Parental leave

Descripción de la vacante

GlaxoSmithKline is seeking a Director of Global Regulatory Strategy– Oncology in a hybrid US role. You will lead regulatory strategies for oncology assets, interact with health authorities, and coordinate cross-functional teams to align with development plans and data availability.

The position emphasizes strong leadership, regulatory intelligence, and strategic recommendations within a matrix environment across major markets, including the US and EU.

Formación

• Bachelor's degree in biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline.
• 8+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry.
• 6+ years of experience supporting drug development programs spanning multiple phases of clinical development.
• 3+ years of experience developing and executing global regulatory strategies for investigational or marketed products in Oncology.
• Experience leading Health Authority interactions, including preparation, execution, and follow-up activities related to regulatory milestone meetings.
• Experience working on cross-functional development teams, including Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions.
• Experience assessing and applying regulatory precedent, regulatory intelligence, and evolving regulatory requirements to development or lifecycle management programs.
• Experience supporting regulatory activities in major global markets, including the United States, European Union, or other international regulatory jurisdictions.
• Experience influencing senior stakeholders and providing strategic regulatory recommendations in a matrix environment.
• Demonstrated experience ensuring compliance with applicable regulatory requirements, industry standards, and company policies throughout the product lifecycle.

Responsabilidades

• Lead or oversee the development and execution of regulatory strategies for assigned assets, ensuring alignment with development plans, integrated evidence strategies, priority market needs, and applicable regulatory requirements.
• Provide regulatory leadership for assigned programs, including assessment of regulatory precedent, regulatory intelligence, competitive landscape, and potential impact on asset strategy.
• Lead, coordinate, or contribute to interactions with health authorities and regulatory review processes, as applicable to assigned programs.
• Work with Early Development Teams, Medicine Development Teams, local regulatory teams, commercial partners, and other cross-functional stakeholders to support regulatory strategy and labeling objectives that are consistent with available data.
• Serve as a point of accountability for assigned regulatory work packages and lead or contribute to Regulatory Matrix Team activities, as applicable.
• Ensure regulatory activities are conducted in accordance with applicable laws, regulations, internal policies, and GSK expectations.
• Provide regulatory input into due diligence, business development, or portfolio-level assessments, as needed.
• Where the role includes people leadership, manage and develop direct or indirect team members, support workforce planning, contribute to resource management, and help build effective, inclusive teams.
• Partner with senior stakeholders to support program-level strategy, resource planning, operating model development, and delivery of longer-term objectives or large-scale initiatives.
• Communicate regulatory strategy, risks, options, and recommendations clearly to senior leaders, health authorities, and cross-functional partners.

Conocimientos

Business Resilience

Communication

Digital Fluency

Matrix Leadership

Pharmaceutical Regulatory Compliance

Regulatory Strategies

Resource Management

Stakeholder Management

Descripción del empleo

GlaxoSmithKline is seeking a Director of Global Regulatory Strategy– Oncology in a hybrid US role. You will lead regulatory strategies for oncology assets, interact with health authorities, and coordinate cross-functional teams to align with development plans and data availability.

The position emphasizes strong leadership, regulatory intelligence, and strategic recommendations within a matrix environment across major markets, including the US and EU.