Global Regulatory Strategy Director

Annexonbioscience; San Francisco (CA); Hybrid; USD 216,000 - 241,000; Full time

Benefits offered by this job

Flexible schedules

Remote opportunities

Equity participation

Health benefits

Job summary

Annexon Biosciences, located in Brisbane, California, seeks a Senior Director of Regulatory Affairs to lead global regulatory strategies for the Annexon portfolio. You will guide regulatory plans, manage agency interactions, and oversee all submissions to authorities such as FDA and EMA, while coordinating with Clinical, CMC, and Quality teams.

You will mentor regulatory staff and external partners, drive risk assessments, and ensure timely, high-quality submissions to support development and

Qualifications

• PhD/PharmD with 12+ years of regulatory affairs leadership experience.
• Experience leading major marketing applications (BLA/NDA/MAA) and submissions.
• Proven ability to influence senior leadership and cross-functional partners.
• Direct experience with FDA and EMA; strong CTD/eCTD understanding.

Responsibilities

• Provide global regulatory leadership and strategic direction for Annexon programs.
• Develop regulatory plans, manage interactions with Health Authorities, and lead submissions.
• Oversee preparation of regulatory documents and lifecycle activities.
• Mentor regulatory professionals and manage external consultants.

Skills

Regulatory leadership

Strategic guidance

FDA/EMA experience

Regulatory writing

Cross-functional leadership

Education

PhD/PharmD with 12+ years

BS/MS/MSN with 14+ years

Tools

CTD/eCTD knowledge

Job description

Annexon Biosciences, located in Brisbane, California, seeks a Senior Director of Regulatory Affairs to lead global regulatory strategies for the Annexon portfolio. You will guide regulatory plans, manage agency interactions, and oversee all submissions to authorities such as FDA and EMA, while coordinating with Clinical, CMC, and Quality teams.

You will mentor regulatory staff and external partners, drive risk assessments, and ensure timely, high-quality submissions to support development and