Associate Director, Regulatory Affairs

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. The Associate Director, Regulatory Affairs reports to the Executive Director of Regulatory Affairs and performs hands‑on regulatory activities across development stages, ensuring high‑quality submissions and effective interactions with health authorities.

Responsibilities

Regulatory Strategy and Program Support

• 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

Health Authority Engagement

• Support preparation for health authority interactions, including briefing packages and response documents
• Participate in agency communications and help track commitments and action items

Regulatory Intelligence and Compliance

• 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

Qualifications

• 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

Pay Range

In the U.S., the hiring pay range for fully qualified candidates is $200,700‑$234,150 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job‑related knowledge, skills, and experience among other factors.

Cytokinetics is an Equal Opportunity Employer.