Global Oncology Regulatory Strategy Director

Regulatory Jobs; Upper Providence (Delaware County); Ibrido; USD 172.000 - 286.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Health insurance

Retirement benefits

Paid holidays

Paid caregiver/parental and medical-le

Descrizione del lavoro

GSK in the United States seeks a Director, Global Regulatory Strategy- Oncology to shape regulatory plans for asset development, aligning with evidence strategies and market needs. You will lead diverse teams across Clinical, Safety, Commercial, CMC, and R&D, engaging health authorities and guiding program objectives.

This role may include people leadership and strategic input into portfolio decisions. This position requires strong leadership, deep regulatory expertise, and a track record of

Competenze

• Bachelor's degree in biology, life sciences, or closely related field.
• 8+ years of Regulatory Affairs experience in pharma/biotech.
• 6+ years supporting drug development across multiple phases.
• 3+ years developing and executing global regulatory strategies in Oncology.

Mansioni

• Lead the development and execution of regulatory strategies for assigned assets.
• Provide regulatory leadership including regulatory precedent and intelligence.
• Lead interactions with health authorities and regulatory reviews.
• Collaborate with Early Development, Medical, and cross-functional teams to align strategy and labeling.
• Mentor and develop regulatory team members where applicable.

Conoscenze

Regulatory strategy

Regulatory leadership

Stakeholder management

Cross-functional collaboration

Strategic communication

Formazione

Bachelor's degree in biology or related field

Advanced degree (MS/PhD/MD or equivalent) in scientific discipline

Descrizione del lavoro

GSK in the United States seeks a Director, Global Regulatory Strategy- Oncology to shape regulatory plans for asset development, aligning with evidence strategies and market needs. You will lead diverse teams across Clinical, Safety, Commercial, CMC, and R&D, engaging health authorities and guiding program objectives.

This role may include people leadership and strategic input into portfolio decisions. This position requires strong leadership, deep regulatory expertise, and a track record of