Associate Director, Regulatory Strategy & Submissions

Cytokinetics; San Francisco (CA); On-site; USD 200,700 - 234,150; Full time

Job summary

Cytokinetics, a specialty cardiovascular biopharmaceutical company, seeks an Associate Director of Regulatory Affairs to lead regulatory activities across development stages and interact with health authorities. You will drive strategies for assigned programs, prepare high-quality submissions, and guide cross-functional teams to ensure compliant, timely regulatory deliverables.

The role requires 8+ years in drug development with strong regulatory experience, excellent communication, and

Qualifications

• Bachelor's degree in a scientific field required; advanced degree is a plus.
• 8+ years of drug development experience including 5+ years in regulatory affairs in biotech/pharma.
• Strong knowledge of FDA, EMA, ICH; experience with GXP.
• Experience supporting regulatory submissions (IND/CTA/eCTD) and health authority interactions.
• Proven ability to manage multiple priorities and work across teams and external partners.

Responsibilities

• Contribute to regulatory strategy and lead regulatory work for assigned programs.
• Identify regulatory risks and develop mitigation plans.
• Provide regulatory guidance to cross-functional teams during product development.
• Lead preparation and submission of high-quality regulatory documents (INDs, CTAs, NDAs).
• Maintain internal regulatory processes, templates, and best practices.

Skills

Regulatory affairs

Communication

Organization

Cross-functional collaboration

Education

Bachelor's degree

Job description

Cytokinetics, a specialty cardiovascular biopharmaceutical company, seeks an Associate Director of Regulatory Affairs to lead regulatory activities across development stages and interact with health authorities. You will drive strategies for assigned programs, prepare high-quality submissions, and guide cross-functional teams to ensure compliant, timely regulatory deliverables.

The role requires 8+ years in drug development with strong regulatory experience, excellent communication, and