Associate Director, Regulatory Affairs

Cytokinetics, Inc.; United States; On-site; USD 200,700 - 234,150; Full time

Job summary

Cytokinetics, Inc. is seeking anAssociate Director, Regulatory Affairs to lead regulatory strategies across development stages and ensure timely, compliant submissions. You will interact with health authorities and guide cross-functional teams through IND/CTA/eCTD processes, staying current with global regulations.

The role requires 8+ years in drug development with significant regulatory experience and strong communication skills to manage multiple priorities and external partners.

Qualifications

• Bachelor's degree in a scientific field required; advanced degree preferred.
• 8+ years of drug development with 5+ years in regulatory affairs.
• Knowledge of FDA/EMA/ICH and GXP requirements.
• Experience supporting submissions (IND/CTA/eCTD) and health authority interactions.
• Ability to manage multiple priorities and coordinate across teams.
• Strong written and verbal communication skills.

Responsibilities

• Contribute to development and execution of regulatory strategies and serve as regulatory lead for assigned programs.
• Identify potential regulatory risks and mitigate them.
• Provide regulatory guidance to cross-functional teams during product development.
• Lead preparation and submission of regulatory documents (INDs, CTAs, NDAs, amendments) and moderately complex submissions.
• Contribute to internal regulatory processes, guidelines, templates and best practices.
• Support health authority interactions, including briefing packages and response documents, and track commitments.
• Stay current with evolving global regulatory requirements and assess impact on programs.

Skills

Regulatory affairs

IND/CTA submissions

FDA/EMA knowledge

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree

Advanced degree

Job description

Associate Director, Regulatory Affairs

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on 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.

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 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; assess potential impact on programs and ensure regulatory activities are conducted in accordance with applicable regulations and company procedures.

Qualifications

• Bachelor's degree required, preferably in a scientific field; advanced degree is a plus.
• 8+ years of drug development experience, 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.

Cytokinetics is an Equal Opportunity Employer.