Director Regulatory Affairs Cytokinetics Inc San Francisco CA
Overview
The Director Regulatory Affairs leads regulatory support for assigned programs ensuring sound regulatory planning and tactical implementation of US and international development strategies. This role reports to the Senior Director overseeing regulatory affairs and drives regulatory strategy for drug approvals. Responsibilities include formulating regulatory strategies managing clinical study collaborations preparing regulatory documents and maintaining compliance with global regulations. The position requires extensive experience in drug development and regulatory affairs with a focus on cardiovascular therapeutics. It offers competitive compensation and opportunities to make an impact on patient care.
What You'll Do11
- 1Formulates regulatory strategies with supervisor oversight to support program objectives and oversees implementation of regulatory strategy and activities needed to secure approval of new drugs
- 2Serves as regulatory affairs lead on assigned clinical studies to support development and execution of global regulatory strategies providing regulatory advice to other functions
- 3Identifies gaps in product development plans that may pose regulatory risks and develops related solutions and mitigation plans
- 4Builds and maintains collaborative relationships with cross-functional project teams other departments vendors and external partners to achieve regulatory goals
- 5Manages coordination preparation and timely submission of regulatory documents filings and responses to queries
- 6Reviews global regulatory submissions for consistency and quality across regions
- 7Ensures conformance to commitments made with regulatory agencies such as IND/CTA commitments and annual obligations
- 8Contributes to regulatory department initiatives including development and maintenance of internal regulatory processes operating guidelines templates and best practices
- 9Supervises employees consultants contractors and interns in Regulatory Affairs mentors department personnel and optimizes employee performance
- 10Drives delivery of regulatory objectives independently while managing multiple priorities
- 11Mentors staff promotes career growth and fosters effective teamwork across functions and external partners
Requirements10
- 110+ years of drug development including at least 7+ years of regulatory affairs experience in the biotech pharmaceutical industry
- 2Advanced degree MD PharmD or PhD preferred
- 3Excellent working knowledge of international regulatory requirements including GXP and eCTD specifications
- 4Proven management expertise including leadership and employee development
- 5Ability to work effectively across teams functions and external partners
- 6Strong oral and written communication skills
- 7Demonstrated organizational and time management abilities with attention to detail
- 8Experience with hybrid work models and flexibility
- 9Commitment to patient-centered approach and ethical standards
- 10Ability to thrive in a fast-paced environment while balancing multiple priorities
Salary Insight
$225 - $262k per year
Location
Required Skills
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