Director, Global Regulatory Lead - Brisbane CA

Military Spouse Corporate Career Network•Brisbane, CA

2d•Hybrid

About The Position

This role involves developing and leading Global and US Regulatory activities for Development Team(s), primarily leveraging external resources for operational activities and internal resources for strategic and Health Authority (HA) engagement. The position requires collaborating with and influencing internal BMS expertise and external regulatory resources to ensure regulatory issues are addressed in development plans. The Director will provide leadership to resolve critical regulatory project issues, establish sound regulatory advice and positions on key development issues, and communicate these to the Development Team Leader (DTL) and other stakeholders. A key responsibility is developing registration strategies for products and translating them into operational deliverables for execution by external and internal resources, including developing alternative plans with associated risks and mitigation strategies. The role also involves providing strategic regulatory input to key development documents and study reports, such as clinical protocols, clinical and nonclinical summary documents, analysis plans, and DMC Charters. Additionally, the Director will provide strategic regulatory input on the target product profile, Core Company Data Sheet (CCDS), and country-specific labels. A critical aspect of the role is creating an asset-specific Global and US HA interactions strategy, integrating regional/local objectives, and leading effective interactions with HAs globally, partnering with regional/local liaisons for execution. The Director will formulate US regulatory strategy and filings, as well as an integrated global submission plan for simultaneous filings, taking accountability for translating this into operational plans delivered by external vendors. This includes the approval of regulatory documents and ensuring documents and regulatory dossiers are compiled according to appropriate standards and guidelines.

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.