Global Regulatory Strategy Director, Oncology

GlaxoSmithKline; Upper Providence (Delaware County); Híbrido; USD 172.000 - 286.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Health insurance

Retirement benefits

Paid holidays

Vacation

Parental leave

Descripción de la vacante

GlaxoSmithKline is seeking a Director, Global Regulatory Strategy- Oncology in the United States to lead and execute regulatory strategies for oncology assets. The role partners with Early Development, Medicine Development, and cross-functional teams to ensure alignment with development plans and regulatory requirements.

The position requires extensive experience in regulatory affairs, leadership of health authority interactions, and a track record in global regulatory strategy across multiple

Formación

• Bachelor's degree in biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or related scientific discipline.
• 8+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry.
• 6+ years supporting drug development programs spanning multiple phases of clinical development.
• 3+ years developing and executing global regulatory strategies for oncology products.
• Experience leading Health Authority interactions, including preparation, execution, and follow-up activities.
• Experience working on cross-functional development teams (Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions).
• Experience assessing regulatory precedent, regulatory intelligence, and evolving regulatory requirements.

Responsabilidades

• Lead and oversee the development and execution of regulatory strategies for assigned assets.
• Provide regulatory leadership for regulatory precedent, regulatory intelligence, and landscape.
• Lead, coordinate, or contribute to interactions with health authorities and regulatory review processes.
• Work with Early Development, Medicine Development, local regulatory teams, and cross-functional partners.
• Serve as a point of accountability for regulatory work packages and matrix team activities.
• Ensure regulatory activities comply with laws, regulations, and internal policies.
• Provide regulatory input into due diligence and portfolio-level assessments.
• Manage and develop direct or indirect team members, supporting workforce planning.

Conocimientos

Regulatory Strategy

Leadership

Cross-functional teamwork

Regulatory Intelligence

Stakeholder Management

Communication

Educación

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

Descripción del empleo

GlaxoSmithKline is seeking a Director, Global Regulatory Strategy- Oncology in the United States to lead and execute regulatory strategies for oncology assets. The role partners with Early Development, Medicine Development, and cross-functional teams to ensure alignment with development plans and regulatory requirements.

The position requires extensive experience in regulatory affairs, leadership of health authority interactions, and a track record in global regulatory strategy across multiple