Cytokinetics is hiring a
Director Regulatory Labeling

Summary

Cytokinetics is seeking an experienced regulatory professional with 10+ years of industry experience for the Director, Regulatory Labeling position. The role involves leading the development of Company Core Data Sheets (CCDS) and global labeling content, participating in Health Authority negotiations, and maintaining knowledge of current rules and regulations governing global labeling activities.

Requirements

• Science based BS or MS degree. Advanced degree (MD, Ph D, PharmD) preferred
• Seasoned regulatory professional with 10+ years of industry experience and extensive experience (at least 6 years) in global regulatory labeling
• Thorough understanding of regulatory labeling requirements and strategic labeling planning
• Direct experience leading labeling content development through regulatory submission and review process, participating in Health Authority negotiations resulting in product approval
• Experience maintaining the CCDS and global labeling throughout the product lifecycle
• Experience leading cross-functional teams and negotiating with internal and external stakeholders on labeling issues
• Strong writing skills; able to process scientific data and effectively summarize into the appropriate detail for labeling content
• Strong interpersonal and communication (written and verbal) skills
• Fluency in English as business language, additional languages advantageous

Responsibilities

• Lead the development of Company Core Data Sheets (CCDS) and global labeling content
• Create and maintain regulatory compliant, competitive, and up to date CCDS for assigned key development projects and marketed products
• Review worldwide labeling against the CCDS and facilitate and track implementation of changes to align with core content
• Participate in label-related Health Authority negotiation meetings
• Contribute to maintenance and updates of labeling processes
• As a member of the Global Regulatory Team, ensure timely implementation of global labeling changes in local product information that are consistent with the company's position defined in the CCDS and in compliance with local labeling regulations
• Review final artwork to be implemented into production, including approval of all change requests for revised labeling for assigned products

Preferred Qualifications

Cardiovascular therapeutic area experience is desirable