Global Regulatory Strategy Director

Bristol Myers Squibb

Lawrence Township (NJ)

On-site

USD 215,000 - 291,964

Full time

14 days+

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Benefits offered by this job

Health coverage

Wellbeing programs

401(k) and life insurance

Job summary

Bristol Myers Squibb is seeking a senior Regulatory Strategist to lead global and US regulatory activities across development teams. You will coordinate internal and external resources, balance clinical plans with regulatory objectives, and drive successful submissions.

The role requires strong communication and leadership across matrix teams. This position emphasizes strategic input on product profiles, regulatory dossiers, and country-specific labeling, with involvement in HA interactions and

Qualifications

Proven success delivering global regulatory strategies coordinating with clinical plans and marketing objectives.
Excellent in communicating regulatory strategy, issues, and risks in written and verbal form.
Experience leading cross-functional matrix teams.
Ability to break down complex scientific issues and communicate regulatory implications.
Proven success negotiating regulatory objectives with health authorities.

Responsibilities

Develop and lead Global and US Regulatory activities for development teams, leveraging external resources for operations.
Collaborate with internal and external regulatory experts to address issues in development plans.
Provide leadership to resolve critical regulatory project issues and coordinate with stakeholders.
Formulate US regulatory strategy and submissions, and create an integrated global plan.