Director, Global Regulatory Lead - Cambridge Crossing MA

Military Spouse Corporate Career Network•Cambridge Crossing, MA

3d•Hybrid

About The Position

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. The intended location for the role is Princeton, New Jersey and hybrid onsite requirements.

Requirements

Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
Significant experience in regulatory affairs (e.g. > 4-7 years)
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 for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement.
Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans
Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed
Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders
Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources
Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies
Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters
Provide strategic regulatory input on the target product profile, CCDS, and country-specific label
Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisons to execute interactions
Formulate US regulatory strategy and filings
Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors
Approval of regulatory documents
Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines