Associate Director, Regulatory Affairs

Cytokinetics • South San Francisco, CA

1d • Hybrid

About The Position

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Reporting to the Executive Director, Regulatory Affairs, the Associate Director, Regulatory Affairs, is responsible for hands-on regulatory activities across development stages, ensuring high-quality submissions and effective interactions with health authorities. The position operates in a highly collaborative, fast-paced biotech environment with significant cross-functional engagement.

Requirements

• Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus
• 8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry
• Excellent working knowledge of global regulatory requirements (FDA, EMA, ICH), including an understanding of GXP
• Experience supporting regulatory submissions (e.g., IND/CTA/eCTD) and health authority interactions
• Proven ability to manage multiple priorities and work effectively across teams, functions and with external partners
• Excellent written and verbal communication skills
• Excellent organizational and product coordination skills

Responsibilities

• Contribute to development and execution of regulatory strategies for assigned programs and serve as regulatory lead for assigned clinical studies
• Identify potential regulatory risks and develop mitigation approaches
• Provide regulatory guidance throughout product development to cross-functional teams such as study operating teams and assigned workstreams
• Lead preparation, review, and timely submission of high-quality, compliant regulatory documents (INDs, CTAs, amendments; NDAs, supplements) and moderately complex regulatory submissions
• Contribute to department initiatives, including the development and maintenance of internal regulatory processes, operating guidelines, templates, and best practices
• Support preparation for health authority interactions, including briefing packages and response documents
• Participate in agency communications and help track commitments and action items
• Stay current with evolving global regulatory requirements, including therapeutic area-specific guidances and scientific developments, and assess potential impact on programs
• Ensure regulatory activities are conducted in accordance with applicable regulations and company procedures

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level