Global Regulatory Strategy Director – Oncology

GlaxoSmithKline; Durham (NC); Híbrido; USD 172.000 - 286.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health care benefits

Annual bonus and long-term incentive

Descripción de la vacante

GSK is seeking a Director of Global Regulatory Strategy- Oncology to lead regulatory strategies for assets across development stages. You will coordinate with cross-functional teams, engage with health authorities, and guide strategy to meet priority market needs.

Hybrid US-based role with leadership meetings and travel as needed. The ideal candidate brings 8+ years in Regulatory Affairs in pharma/biotech, with 3+ years in Oncology regulatory strategy and demonstrated leadership in a global

Formación

• Bachelor's degree in biology or regulatory science or related field.
• 8+ years of experience in Regulatory Affairs within pharma/biotech.
• 6+ years of experience supporting drug development across multiple phases.
• 3+ years developing and executing global regulatory strategies in Oncology.
• Experience leading Health Authority interactions.
• Experience working with cross-functional development teams.
• Experience applying regulatory precedent and evolving regulatory requirements.
• Experience in major global markets including US/EU.

Responsabilidades

• Lead development and execution of regulatory strategies for assigned assets.
• Provide regulatory leadership with assessment of precedent and regulatory intelligence.
• Lead interactions with health authorities and regulatory review processes.
• Collaborate with Early Development, Medicine Development, local regulatory teams, and cross-functional partners.
• Be accountable for regulatory work packages and participate in Regulatory Matrix Team activities.
• Ensure activities comply with laws, regulations, and internal policies.
• Contribute to due diligence, BD, or portfolio-level assessments.
• Mentor and develop team members in a global matrix setting.
• Partner with senior stakeholders for program-level strategy and resource planning.
• Clearly communicate strategy, risks, and recommendations to senior leaders and partners.

Conocimientos

Regulatory strategy

Cross-functional collaboration

Regulatory leadership

Stakeholder management

Strategic regulatory recommendations

Regulatory intelligence

Educación

Bachelor's degree in biology/Life Sciences/Regulatory Science

Advanced degree (MS/PhD/MD)

Descripción del empleo

GSK is seeking a Director of Global Regulatory Strategy- Oncology to lead regulatory strategies for assets across development stages. You will coordinate with cross-functional teams, engage with health authorities, and guide strategy to meet priority market needs.

Hybrid US-based role with leadership meetings and travel as needed. The ideal candidate brings 8+ years in Regulatory Affairs in pharma/biotech, with 3+ years in Oncology regulatory strategy and demonstrated leadership in a global