Global Regulatory Strategy Leader

Regulatory Jobs; Princeton (NJ); Hybrid; USD 215,000 - 260,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Paid time off

Job summary

Bristol Myers Squibb invites a seasoned regulatory leader to drive global regulatory strategies for development programs in the US and globally. You will coordinate with clinical, regulatory operations and marketing teams to ensure alignment with filing plans and project milestones.

This role emphasizes strategy development, expert input on submissions, and proactive risk management, with a hybrid onsite work arrangement in Princeton, NJ.

Qualifications

• Proven success in delivering global regulatory strategies aligned with clinical and marketing plans.
• Excellent communication of regulatory strategy, issues and risks in written and verbal form.
• Experience leading cross functional matrix teams and coordinating with health authorities.

Responsibilities

• Develop and lead Global and US Regulatory activities, leveraging external resources for operations and internal resources for strategy.
• Provide leadership to resolve critical regulatory project issues and assemble the right experts as needed.
• Establish regulatory positions on key development issues and communicate to stakeholders.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory communication

Risk management

Negotiation with regulatory bodies

Education

PhD, MD, PharmD, MS or BS

Job description

Bristol Myers Squibb invites a seasoned regulatory leader to drive global regulatory strategies for development programs in the US and globally. You will coordinate with clinical, regulatory operations and marketing teams to ensure alignment with filing plans and project milestones.

This role emphasizes strategy development, expert input on submissions, and proactive risk management, with a hybrid onsite work arrangement in Princeton, NJ.