Director, Regulatory Affairs

Cytokinetics, Inc.; United States; Hybrid; USD 225,000 - 262,500; Full time

Job summary

Cytokinetics, Inc. is seeking a Director of Regulatory Affairs to lead regulatory support for various programmes essential to the development of cardiac muscle therapeutics. This role requires formulating regulatory strategies, overseeing their implementation, and ensuring compliance with both US and international guidelines.

The ideal candidate will possess over 10 years of drug development experience, with at least 7 years in regulatory affairs. A Bachelor's degree is mandatory, and an advanced degree is preferred. The position supports a hybrid working environment, offering a competitive salary range.

Qualifications

• 10+ years in drug development with at least 7+ years in regulatory affairs.
• Strong knowledge of international regulatory requirements and GXP.
• Excellent communication and organizational skills.

Responsibilities

• Lead regulatory support for assigned programmes.
• Identify gaps in product development plans and create mitigation strategies.
• Manage coordination and submission of regulatory documents.

Skills

Regulatory strategy formulation

Cross-functional collaboration

Regulatory submissions expertise

Leadership and management

Attention to detail

Education

Bachelor’s degree in scientific discipline

Advanced degree (MD, PharmD, or PhD)

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company focused on developing small‑molecule therapeutics for cardiac muscle dysfunction. The Director, Regulatory Affairs reports to the Senior Director, Regulatory Affairs and is responsible for leading regulatory support for assigned programmes to ensure sound regulatory planning and tactical implementation of US and international development strategies.

Responsibilities

• Formulate regulatory strategies, with supervisor oversight, to support programme objectives and oversee their implementation.
• Serve as the regulatory affairs lead on assigned clinical studies, supporting global regulatory strategies and providing regulatory advice to other functions.
• Identify gaps in product development plans that may pose regulatory risks and develop mitigation plans.
• Build and maintain collaborative relationships with cross‑functional project teams, vendors and external partners to achieve programme regulatory goals.
• Manage coordination, preparation and timely submission of regulatory documents, filings and responses to queries.
• Review global regulatory submissions for consistency and quality across regions.
• Maintain current knowledge of laws, regulations and guidelines (eg, FDA, EMA, ICH, CDE, PMDA).
• Ensure conformance to commitments made with regulatory agencies (eg, IND/CTA commitments, annual obligations).
• Contribute to regulatory department initiatives, including the development and maintenance of internal regulatory processes, operating guidelines, templates and best practices.
• Supervise employees, consultants/contractors and interns in Regulatory Affairs.
• Mentor department personnel and optimise employee performance through development and career growth initiatives.

Qualifications

• 10+ years of drug development, including at least 7+ years of regulatory affairs experience in the biotech/pharmaceutical industry; small‑molecule drug development experience preferred and cardiovascular therapeutic area a plus.
• Bachelor’s degree required, preferably in a scientific discipline; advanced degree (MD, PharmD, or PhD) a plus.
• Excellent working knowledge of international regulatory requirements and environment applicable to the clinical development and post‑marketing space, including an understanding of GXP.
• Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions.
• Experience with eCTD requirements and electronic submissions.
• Experience with international regulatory submissions and processes (eg, Canada, Greater China, Japan) is a strong plus.
• Demonstrated management expertise, including leadership and development of employees.
• Ability to work effectively across teams, functions and with external partners.
• Excellent oral and written communication skills.
• Excellent organisational and time‑management skills, attention to detail, and ability to independently drive deliverables to completion.
• Ability to work effectively in a fast‑paced environment while managing multiple priorities.

Pay Range

In the U.S., the hiring pay range for fully qualified candidates is $225,000 – $262,500 per year. The base pay offered will consider internal equity and may vary based on geographic region, job‑related knowledge, skills and experience.

Hybrid work environment (#LI-HYBRID).

Cytokinetics is an Equal Opportunity Employer.