Senior Director, Global Regulatory Affairs Counsel

BioMarin Pharmaceutical Inc.; San Rafael (CA); Hybrid; USD 260.000 - 380.000; Vollzeit

Zusammenfassung

BioMarin Pharmaceutical Inc. is seeking an experienced Senior Director, Corporate Counsel, Global Regulatory Affairs to lead regulatory strategy across the full lifecycle of BioMarin's therapies.

This hybrid role can be onsite in San Rafael, CA, or remote from Washington, DC, and collaborates with Regulatory Affairs, Clinical Development, Medical Affairs, Pharmacovigilance, Quality, and Commercial teams. The successful candidate will provide strategic, risk-based legal guidance on global

Qualifikationen

• J.D. and active state bar in the U.S.
• Minimum of 12 years of post‑J.D. regulatory experience in pharma/biotech.
• Deep knowledge of FDA drug/biologic development, labeling, and pharmacovigilance.
• Experience guiding regulatory submissions, agency interactions, and lifecycle management.
• Strong business acumen and ability to influence senior leaders.

Aufgaben

• Serve as the primary legal advisor to BioMarin's Global Regulatory Affairs, providing risk-based regulatory counsel.
• Advise on FDA interactions and global health authority engagements.
• Develop and oversee global regulatory strategies to support development and lifecycle management.
• Provide guidance on regulatory submissions, labeling, and post-marketing activities.
• Lead cross-functional teams and manage outside counsel for regulatory projects.

Kenntnisse

Regulatory strategy

Legal counsel

Regulatory affairs

Leadership

Strategic advisory

Ausbildung

Juris Doctor (J.D.)

Jobbeschreibung

BioMarin Pharmaceutical Inc. is seeking an experienced Senior Director, Corporate Counsel, Global Regulatory Affairs to lead regulatory strategy across the full lifecycle of BioMarin's therapies.

This hybrid role can be onsite in San Rafael, CA, or remote from Washington, DC, and collaborates with Regulatory Affairs, Clinical Development, Medical Affairs, Pharmacovigilance, Quality, and Commercial teams. The successful candidate will provide strategic, risk-based legal guidance on global