Global Regulatory Affairs Counsel Director — Hybrid/Remote

BioMarin Pharmaceutical; San Rafael (CA); Hybrid; USD 250,000 - 350,000; Full time

Job summary

BioMarin is seeking an experienced Senior Director, Corporate Counsel for Global Regulatory Affairs to serve as the lead legal advisor to Regulatory Affairs, guiding strategies from early development through global registration and post‑approval activities.

You will partner with cross‑functional teams across Clinical Development, Medical Affairs, Pharmacovigilance, Quality, and Commercial to navigate FDA and other health authorities, shape labeling, lifecycle management, and regulatory

Qualifications

• J.D. degree and active bar membership in at least one state.
• Minimum of 12 years post‑J.D. experience in pharma/regulatory law.
• Deep knowledge of FDA requirements governing drug/biologic development.

Responsibilities

• Advise Global Regulatory Affairs on regulatory submissions and agency interactions.
• Develop global regulatory strategies to support development, registration, and lifecycle management.
• Provide strategic guidance on labeling, pharmacovigilance, and post‑marketing requirements.
• Collaborate with Legal, Compliance, Quality, Medical Affairs, and Commercial teams.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Regulatory risk assessment

Education

Juris Doctor (J.D.)

California Bar eligibility

Job description

BioMarin is seeking an experienced Senior Director, Corporate Counsel for Global Regulatory Affairs to serve as the lead legal advisor to Regulatory Affairs, guiding strategies from early development through global registration and post‑approval activities.

You will partner with cross‑functional teams across Clinical Development, Medical Affairs, Pharmacovigilance, Quality, and Commercial to navigate FDA and other health authorities, shape labeling, lifecycle management, and regulatory