Global Labeling Senior Manager - Hybrid/Remote

Revolution Medicines; United States; Híbrido; USD 150.000 - 189.000; Jornada completa

Descripción de la vacante

Revolution Medicines is seeking a Senior Manager of Labeling to develop and maintain regional labeling aligned with global CCDS strategy. The role oversees cross-functional reviews, coordinates with external vendors, and ensures timely delivery of labeling documents for regulatory submissions.

The position can be based in Redwood City, CA in a hybrid setup or remote with travel; strong collaboration with Global Labeling is required and experience across multiple regions is essential.

Formación

• Bachelor's degree in scientific, pharmacy, life sciences, or related discipline.
• 7+ years in pharma/biotech regulatory labeling across multiple geographies.
• Ability to review regulatory labeling documents for accuracy and regulatory compliance.
• Experience drafting regional labeling from CCDS or reference label.
• Experience overseeing external labeling vendors and submissions across regions.
• Experience with electronic document management and version control.

Responsabilidades

• Partner with the Global Labeling Lead to translate strategy into regional labeling plans and timelines.
• Author and maintain regional prescribing information using CCDS or reference labels.
• Assess impact of CCDS changes and coordinate updates with regional Regulatory Affairs.
• Identify differences between local labeling and CCDS; escalate deviations.
• Oversee vendor performance and ensure quality, timelines, and approvals.

Conocimientos

Regulatory labeling experience

Project management

Cross-functional communication

Attention to detail

Educación

Bachelor's degree in life sciences

Advanced degree preferred

Herramientas

Regulatory information management systems

Document management systems

Descripción del empleo

Revolution Medicines is seeking a Senior Manager of Labeling to develop and maintain regional labeling aligned with global CCDS strategy. The role oversees cross-functional reviews, coordinates with external vendors, and ensures timely delivery of labeling documents for regulatory submissions.

The position can be based in Redwood City, CA in a hybrid setup or remote with travel; strong collaboration with Global Labeling is required and experience across multiple regions is essential.