Director, Regulatory Affairs
Cytokinetics
August 23, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Responsibilities:
- Formulate regulatory strategies (with supervisor oversight) to support program objectives and oversee implementation to secure approval of new drugs.
- Serve as a regulatory affairs lead on assigned clinical studies to support global regulatory strategy and provide regulatory advice to other functions.
- Identify regulatory risks in product development plans and develop solutions and mitigation plans.
- Build and maintain collaborative relationships with cross-functional teams, departments, vendors, and external partners.
- Coordinate, prepare, and submit regulatory documents, filings, and responses to queries.
- Review global regulatory submissions for consistency and quality across regions.
- Maintain current knowledge of applicable laws, regulations, and guidelines (e.g., FDA, EMA, ICH, CDE, PMDA).
- Ensure conformance to regulatory commitments (e.g., IND/CTA commitments, annual obligations).
- Contribute to regulatory department initiatives, including internal processes, operating guidelines, templates, and best practices.
- Supervise Regulatory Affairs employees, consultants/contractors, and/or interns.
- Mentor personnel and optimize performance by developing employees and promoting career growth.
Qualifications:
- 10+ years drug development, including 7+ years regulatory affairs experience in Biotech/Pharma (small molecule preferred; cardiovascular area a plus).
- Bachelor’s degree required (scientific preferred); MD/PharmD/PhD a plus.
- Knowledge of international regulatory requirements for clinical development and post-marketing, including GXP.
- Experience with clinical trial regulatory requirements and preparation of regulatory submissions.
- Experience with eCTD and electronic submissions.
- International submission/process experience (Canada, Greater China, Japan) strong plus.
- Demonstrated management expertise and leadership.
- Strong cross-functional and external partner collaboration.
- Excellent oral/written communication; strong organizational/time management and attention to detail.
Application instructions:
- Please review the General Data Protection Regulation (GDPR) policy prior to applying.
- Formulate regulatory strategies (with supervisor oversight) to support program objectives and oversee implementation to secure approval of new drugs.
- Serve as a regulatory affairs lead on assigned clinical studies to support global regulatory strategy and provide regulatory advice to other functions.
- Identify regulatory risks in product development plans and develop solutions and mitigation plans.
- Build and maintain collaborative relationships with cross-functional teams, departments, vendors, and external partners.
- Coordinate, prepare, and submit regulatory documents, filings, and responses to queries.
- Review global regulatory submissions for consistency and quality across regions.
- Maintain current knowledge of applicable laws, regulations, and guidelines (e.g., FDA, EMA, ICH, CDE, PMDA).
- Ensure conformance to regulatory commitments (e.g., IND/CTA commitments, annual obligations).
- Contribute to regulatory department initiatives, including internal processes, operating guidelines, templates, and best practices.
- Supervise Regulatory Affairs employees, consultants/contractors, and/or interns.
- Mentor personnel and optimize performance by developing employees and promoting career growth.
Qualifications:
- 10+ years drug development, including 7+ years regulatory affairs experience in Biotech/Pharma (small molecule preferred; cardiovascular area a plus).
- Bachelor’s degree required (scientific preferred); MD/PharmD/PhD a plus.
- Knowledge of international regulatory requirements for clinical development and post-marketing, including GXP.
- Experience with clinical trial regulatory requirements and preparation of regulatory submissions.
- Experience with eCTD and electronic submissions.
- International submission/process experience (Canada, Greater China, Japan) strong plus.
- Demonstrated management expertise and leadership.
- Strong cross-functional and external partner collaboration.
- Excellent oral/written communication; strong organizational/time management and attention to detail.
Application instructions:
- Please review the General Data Protection Regulation (GDPR) policy prior to applying.