Global Regulatory Affairs Director for Drug Development

Cytokinetics; South San Francisco (CA); Hybrid; USD 225,000 - 263,000; Full time

Job summary

Cytokinetics, a specialty cardiovascular biopharmaceutical company, seeks a Director to lead regulatory strategies for US and international development programs from South San Francisco. Reporting to the Senior Director of Regulatory Affairs, you will drive regulatory submissions, ensure FDA/EMA/ICH compliance, mentor staff, and coordinate cross‑functional teams to advance clinical studies.

This hybrid role offers a competitive base salary and growth opportunities, reflecting experience and

Qualifications

• 10+ years of drug development experience with regulatory leadership responsibilities.
• 7+ years in regulatory affairs within Biotech/Pharma, cardiovascular focus preferred.
• Experience with international regulatory submissions and eCTD.
• Strong written and oral communication; leadership and mentoring abilities.

Responsibilities

• Formulates and leads regulatory strategies for global programs.
• Acts as regulatory lead on clinical studies and advises cross-functional teams.
• Manages preparation and timely submission of regulatory documents and responses.
• Maintains current knowledge of FDA/EMA/ICH/GXP requirements and milestones.

Skills

Regulatory leadership

Drug development

Cross-functional collaboration

eCTD experience

Education

Bachelor's degree

Advanced degree (MD/PharmD/PhD)

Job description

Cytokinetics, a specialty cardiovascular biopharmaceutical company, seeks a Director to lead regulatory strategies for US and international development programs from South San Francisco. Reporting to the Senior Director of Regulatory Affairs, you will drive regulatory submissions, ensure FDA/EMA/ICH compliance, mentor staff, and coordinate cross‑functional teams to advance clinical studies.

This hybrid role offers a competitive base salary and growth opportunities, reflecting experience and