Director, Regulatory Labeling

August 29

Apply Now

Receive Emails with Similar Jobs

Cytokinetics

WebsiteLinkedInAll Job Openings

Empowering Muscle Empowering Lives

Heart Failure • Amyotrophic Lateral Sclerosis • Hypertrophic Cardiomyopathy

201 - 500

💰 $450M Post-IPO Debt on 2022-06

Description

• Cytokinetics is a biopharmaceutical company focused on muscle activators and inhibitors. • Lead Global Labeling for development and marketed products. • Collaborate with stakeholders for regulatory compliance. • Review and implement labeling changes with Health Authorities. • Maintain knowledge of global labeling regulations and practices.

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 • Cardiovascular therapeutic area experience is desirable