Senior Director, US Regulatory Strategy

Regulatory Jobs; United States; À distance; USD 211 000 - 281 000; Plein temps

Résumé du poste

BeOne Medicines Ltd. seeks a Senior Director, Regulatory Affairs to shape US regulatory direction and manage FDA engagement across a development portfolio and marketed products.

You’ll provide strategic leadership from discovery through lifecycle management, balancing scientific and business needs to accelerate approvals and sustain product value. You will lead cross-functional teams, negotiate with the FDA, and drive MS Office, Veeva publishing, and regulatory submissions for INDs/NDAs/BLAs,

Qualifications

• 15+ years in pharmaceutical/biotech with U.S. regulatory leadership experience.
• Proven track record leading complex US regulatory strategies for oncology portfolios.
• Direct FDA interaction experience and significant regulatory accomplishments.

Responsabilités

• Lead development and execution of integrated US regulatory strategies for products and programs.
• Represent Regulatory Affairs on senior teams and coordinate FDA engagements.
• Oversee submission planning of INDs, NDAs, BLAs, and regulatory filings.
• Develop risk assessments and mitigation plans across development stages.

Connaissances

FDA engagement leadership

Regulatory strategy

Cross-functional collaboration

Regulatory risk management

Formation

Bachelor's degree in scientific or health-related discipline

Advanced scientific/medical/regulatory degree preferred

Outils

Microsoft Office

Veeva regulatory publishing

PowerPoint presentation

Description du poste

BeOne Medicines Ltd. seeks a Senior Director, Regulatory Affairs to shape US regulatory direction and manage FDA engagement across a development portfolio and marketed products.

You’ll provide strategic leadership from discovery through lifecycle management, balancing scientific and business needs to accelerate approvals and sustain product value. You will lead cross-functional teams, negotiate with the FDA, and drive MS Office, Veeva publishing, and regulatory submissions for INDs/NDAs/BLAs,