Director, Global Regulatory Affairs & Strategy (Hybrid)

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

Job summary

Cytokinetics, a cardiovascular biopharmaceutical company, is seeking a Director of Regulatory Affairs to lead regulatory strategy for US and international programs. The role requires deep expertise in global regulatory affairs, strong leadership, and cross-functional collaboration to ensure timely approvals and compliance across regions.

The position reports to the Senior Director, Regulatory Affairs, and supports the development and execution of regulatory strategies for a robust clinical

Qualifications

• 10+ years of drug development with 7+ years in regulatory affairs.
• Bachelor’s degree, advanced degree a plus.
• Strong knowledge of global regulatory requirements (FDA, EMA, ICH).

Responsibilities

• Formulates and leads regulatory strategies to support program objectives.
• Acts as regulatory lead on clinical studies for global strategies.
• Manages regulatory submissions, responses, and timelines across regions.
• Maintains knowledge of regulatory requirements and guides cross-functional teams.
• Mentors regulatory staff and fosters career growth.

Skills

Regulatory strategy

Regulatory leadership

Cross-functional collaboration

Regulatory submissions

Regulatory communications

Education

Bachelor's degree

Advanced degree (MD/PhD/PharmD)

Tools

eCTD submissions

Job description

Cytokinetics, a cardiovascular biopharmaceutical company, is seeking a Director of Regulatory Affairs to lead regulatory strategy for US and international programs. The role requires deep expertise in global regulatory affairs, strong leadership, and cross-functional collaboration to ensure timely approvals and compliance across regions.

The position reports to the Senior Director, Regulatory Affairs, and supports the development and execution of regulatory strategies for a robust clinical