Contract Opportunities

Global Regulatory Lead – Cardiovascular

Contract: 16 weeks

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We are seeking an experienced Global Regulatory Lead (GRL) to provide coverage for medical leave within a key regulatory leadership position.

This individual will lead global regulatory strategy and execution across CV and Cardiovascular programs.

The Role

Expected Areas of Competence:

Serve as Global Regulatory Lead (GRL) and/or US Regulatory Lead (USRL) for a cardiovascular Development Team, providing strategic regulatory leadership through key late-stage milestones, including Database Lock (DBL) this year, and driving preparation for the original NDA submission currently underway.
Provide global submission leadership and oversight, ensuring integrated planning, cross-functional alignment, issue escalation, and high-quality execution across regions and submission workstreams
Operate effectively within a collaboration partnership, aligning regulatory strategy, roles, decision-making, and execution plans across internal teams and partner organizations• 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 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)
Previous cardiovascular experience• Previous filing experience highly preferred
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.
Candidates must be based in the United States.
Remote working is acceptable.
Ability and willingness to travel occasionally for important meetings and business-critical activities.
Immediate availability or ability to start at short notice is strongly preferred.

Behaviors:

Translates broad strategies into specific objectives and action plans that can be effectively executed by external partners.
Sets challenging, but regulatory achievable objectives, comfortable taking risk in the regulatory setting
Generates alternative regulatory strategies and plans, and assesses benefits and risks.
Develops contingency plans and meets challenges necessary to execute business and action plans. Ensures these plans are feasible using external resources.
Creates a unified and seamless team using both internal and external resources to execute regulatory strategy
Communicates opinions, facts and thoughts with clarity, transparency and honesty.
Seeks multiple perspectives and listens openly to others’ points of views.
Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.
Demonstrates ownership of results within (and beyond) area of responsibility.
Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
Develops and applies unique ideas and new methods to achieve higher performance and excellence.
Works across organizational, functional and geographic boundaries to achieve company goals.
Creates an environment that encourages continuous improvement, innovation and appropriate risk taking.
Demonstrates resilience and perseverance.