Associate Director, Regulatory Labeling - Remote

Overview

The Associate Director, Regulatory Labeling is a regulatory labeling leader with expert technical and operational experience in regulatory labeling, globally, and is responsible for overseeing the development, implementation and maintenance of global product labeling content and strategy for products across various stages of drug development.

In Short

• Oversee global product labeling content and strategy.
• Responsible for regulatory labeling across various drug development stages.
• Generate Scholar Rock labeling process.
• Coordinate creation of Company Core Data Sheet (CCDS).
• Develop Prescribing Information (PI) and Patient Information Leaflet (PIL).
• Coordinate and run the Labeling Working Group (LWG).
• Ensure compliance with labeling regulations and guidance.
• Work with products in select markets, typically US and EU.
• Utilize expert technical and operational experience in regulatory labeling.
• Contribute to innovative treatments in biopharmaceuticals.

Requirements

• Expertise in regulatory labeling.
• Experience in drug development processes.
• Strong understanding of global labeling regulations.
• Ability to coordinate cross-functional teams.
• Experience with Company Core Data Sheet (CCDS) creation.
• Knowledge of Prescribing Information (PI) and Patient Information Leaflet (PIL) requirements.
• Strong communication and leadership skills.
• Detail-oriented with strong organizational skills.
• Ability to work in a fast-paced environment.
• Experience in biopharmaceutical industry preferred.

Benefits

• Opportunity to work on innovative therapies.
• Collaborative work environment.
• Competitive salary and benefits package.
• Professional development opportunities.
• Contribute to meaningful patient outcomes.
• Work with a dedicated team of professionals.
• Access to cutting-edge science and technology.
• Flexible work arrangements.
• Supportive company culture.
• Engagement in impactful projects.