Hybrid Global Regulatory Strategy Lead

Bristol-Myers Squibb Co; Alabama; Hybrid; USD 210,000 - 291,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) plan

Paid time off & holidays

Global team collaboration

Job summary

Bristol Myers Squibb Co is seeking a Director-level Global Regulatory Lead to drive global regulatory strategies for development programs, coordinating with clinical plans and marketing objectives. The role emphasizes leadership across cross-functional teams and strategic HA interactions to secure timely registrations.

The position involves formulating regulatory strategies, filings, and interaction plans across US and global teams, with accountability for delivering integrated submission plans

Qualifications

• Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration.
• Excellent in communicating regulatory strategy, issues, and risks in written and verbal format.
• Experience leading cross functional matrix teams.
• Demonstrated ability to break down complex, scientific issue and communicating regulatory implications.
• Proven success in negotiating regulatory objectives with HA

Responsibilities

• Develop and lead Global and US Regulatory activities leveraging external resources for operations and internal resources for strategy.
• Provide strategic regulatory input to key development documents and study reports.
• Formulate US regulatory strategy and filings and develop global submission plans.
• Create asset-specific HA interactions strategy and lead effective interactions globally.

Skills

Global regulatory strategy

Regulatory leadership

Cross-functional leadership

HA negotiations

Job description

Bristol Myers Squibb Co is seeking a Director-level Global Regulatory Lead to drive global regulatory strategies for development programs, coordinating with clinical plans and marketing objectives. The role emphasizes leadership across cross-functional teams and strategic HA interactions to secure timely registrations.

The position involves formulating regulatory strategies, filings, and interaction plans across US and global teams, with accountability for delivering integrated submission plans