Cytokinetics · 2 hours ago

Director, Regulatory Labeling (REMOTE)

Remote - United States

Full-time

Remote

Director/Executive

10+ years exp

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Responsibilities

The Global Labeling Lead is responsible for leading the development of Company Core Data Sheets (CCDS) and global labeling content (focus on US, EU and Canada), as applicable across regions through collaboration with key internal stakeholders

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

Maintain knowledge of current rules and regulations governing global labeling activities

Participate in interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices, and align with global strategic plan

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory labelingCCDS maintenanceHealth Authority negotiationsCross-functional team leadershipFluency in EnglishCardiovascular experience

Required

Science based BS or MS degree.

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.