Global Regulatory Strategy Lead

VetJobs; Seattle (WA); Hybrid; USD 241,000 - 292,000; Full time

Job summary

Bristol Myers Squibb is seeking an experienced Regulatory Affairs leader to guide global and US regulatory activities for development teams. The role involves shaping registration strategies, coordinating with external partners, and providing strategic input to clinical and nonclinical documentation.

The position supports global submissions and cross-functional collaboration, with hybrid onsite requirements.

Qualifications

• Solid scientific background with Ph.D., M.D., PharmD, MS, or BS

Responsibilities

• Lead and manage global and US regulatory activities for development teams, leveraging external resources for operations and internal resources for strategy and HA engagement.
• Provide strategic regulatory input to development documents, study reports, and regulatory submissions.
• Develop and execute registration strategies for products, including global submissions and country-specific filings.
• Communicate regulatory positions to stakeholders and resolve issues impacting development plans.

Job description

Bristol Myers Squibb is seeking an experienced Regulatory Affairs leader to guide global and US regulatory activities for development teams. The role involves shaping registration strategies, coordinating with external partners, and providing strategic input to clinical and nonclinical documentation.

The position supports global submissions and cross-functional collaboration, with hybrid onsite requirements.