Director, US Regulatory Lead, GRS
Bristol Myers Squibb
5 days ago
Remote friendly (Madison, NJ)
United States
Corporate Functions
Director, US Regulatory Lead (GRS)
Position Summary
Oversee U.S. regulatory strategy and execution for Immunology and Cardiovascular therapeutic area, with primary focus on pulmonology asset management and Health Authority (HA) interactions, including upcoming NDA submission. May also serve as Global Regulatory Lead (GRL)/USRL for early or late development assets, leading IND preparation/submission and lifecycle regulatory strategy.
Responsibilities / Expected Areas of Competence
- Develop and lead U.S. regulatory strategy/execution, including first NDA submission; ensure compliance with FDA commitments/timelines.
- Lead HA interactions (pre-NDA meetings, briefing packages, response documents, FDA correspondence).
- Build U.S. registration strategy and translate into operational deliverables; partner with GRL and cross-functional teams.
- Provide strategic regulatory input on target product profile, CCDS, and USPI.
- Develop alternative/regulatory risk-mitigating plans; lead contingency planning.
- Lead IND preparation/filing and lifecycle strategy for applicable assets.
- Influence internal/external regulatory resources; resolve critical regulatory project issues.
- Provide regulatory input to key documents/study reports (clinical/nonclinical protocols, reports/summaries, analysis plans, DMC charters).
- Ensure dossiers are compiled per standards/guidelines.
Degree / Experience Requirements
- Ph.D., M.D., PharmD, MS, or BS; solid scientific background.
- Regulatory affairs experience (>4–7 years), with at least 3 years in the U.S.; preferably pulmonology and immunology.
Qualifications / Skills (required)
- Proven success delivering U.S. regulatory strategies with clinical/marketing alignment to successful registration.
- Strong written/verbal communication of strategy, issues, and risks.
- Experience leading cross-functional matrix teams.
- Ability to break down complex scientific issues and communicate regulatory implications.
- Proven success negotiating HA regulatory objectives.
Benefits (explicit)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability/life insurance, and other listed financial/protection benefits.
Application Instructions
- If the role intrigues you but doesn’t fully match your resume, apply anyway.
Position Summary
Oversee U.S. regulatory strategy and execution for Immunology and Cardiovascular therapeutic area, with primary focus on pulmonology asset management and Health Authority (HA) interactions, including upcoming NDA submission. May also serve as Global Regulatory Lead (GRL)/USRL for early or late development assets, leading IND preparation/submission and lifecycle regulatory strategy.
Responsibilities / Expected Areas of Competence
- Develop and lead U.S. regulatory strategy/execution, including first NDA submission; ensure compliance with FDA commitments/timelines.
- Lead HA interactions (pre-NDA meetings, briefing packages, response documents, FDA correspondence).
- Build U.S. registration strategy and translate into operational deliverables; partner with GRL and cross-functional teams.
- Provide strategic regulatory input on target product profile, CCDS, and USPI.
- Develop alternative/regulatory risk-mitigating plans; lead contingency planning.
- Lead IND preparation/filing and lifecycle strategy for applicable assets.
- Influence internal/external regulatory resources; resolve critical regulatory project issues.
- Provide regulatory input to key documents/study reports (clinical/nonclinical protocols, reports/summaries, analysis plans, DMC charters).
- Ensure dossiers are compiled per standards/guidelines.
Degree / Experience Requirements
- Ph.D., M.D., PharmD, MS, or BS; solid scientific background.
- Regulatory affairs experience (>4–7 years), with at least 3 years in the U.S.; preferably pulmonology and immunology.
Qualifications / Skills (required)
- Proven success delivering U.S. regulatory strategies with clinical/marketing alignment to successful registration.
- Strong written/verbal communication of strategy, issues, and risks.
- Experience leading cross-functional matrix teams.
- Ability to break down complex scientific issues and communicate regulatory implications.
- Proven success negotiating HA regulatory objectives.
Benefits (explicit)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability/life insurance, and other listed financial/protection benefits.
Application Instructions
- If the role intrigues you but doesn’t fully match your resume, apply anyway.