Senior Manager/Associate Director, International Regulatory Affairs

Responsibilities

• Develop Japanese regulatory filing strategies and identify potential risks or gating factors.
• Lead the strategic planning and preparation of complex submissions, including JNDA/JsNDA, post-marketing maintenance, and expedited pathway applications.
• Serve as the primary liaison with Japanese regulatory authorities, including MHLW and PMDA.
• Lead the preparation and execution of agency meetings.
• Interface with U.S. and global BioMarin offices to align on operational and strategic deliverables.
• Evaluate emerging regulations and guidance to advise the company on the Japanese regulatory environment.

Requirements

• Bachelor of Science degree in life science.
• Minimum of 10 years of industry experience.
• At least 6 years of Regulatory Affairs experience within the biotechnology or pharmaceutical industries.
• Proven track record of preparing, submitting, and gaining approvals for JNDAs.
• Deep knowledge of the Japanese regulatory environment and drug development guidelines.
• Fluency in both Japanese and English (verbal and technical written).
• Strong interpersonal, communication, and collaborative skills.

Preferred Qualifications

• Qualified Pharmacist designation.
• Experience as a clinical scientist.
• In-depth understanding of clinical development from a regulatory strategist perspective.

About the Company

BioMarin is a global biotechnology company dedicated to developing and delivering innovative therapies for people with serious and life-threatening genetic diseases.