Global Regulatory Affairs Lead

Medasource; New Jersey; On-site; USD 150,000 - 210,000; Full time

Job summary

Medasource is seeking a Global Regulatory Lead (GRL) / US Regulatory Lead (USRL) for a late-stage cardiovascular development program in New Jersey. The role will oversee regulatory strategy for the Milvexian indication and act as the primary regulatory lead in the U.S.

and globally. The position requires a solid scientific background (PhD/MD/PharmD/MS/BS) and 4–7+ years in Regulatory Affairs, with proven experience leading regulatory strategy, submissions, and health authority interactions.

Qualifications

• Solid scientific background in a relevant scientific discipline (PhD/MD/PharmD/MS/BS).
• 4–7+ years of Regulatory Affairs experience.
• Experience serving as Global Regulatory Lead (GRL) and/or U.S. Regulatory Lead (USRL).

Responsibilities

• Provide Global Regulatory Leadership for a late-stage cardiovascular program and act as GRL/USRL for the Milvexian indication.
• Drive NDA preparation and global submission leadership with cross-functional alignment and high-quality execution.
• Develop and execute Health Authority engagement strategies globally and in the U.S.
• Lead cross-functional teams and align governance, decision-making, and execution across partner organizations.
• Provide strategic regulatory input to protocols, studies, reports, labeling strategies, and submissions.

Skills

Regulatory leadership

Cross-functional communication

Strategic thinking

Stakeholder management

Education

PhD

MD

PharmD

MS

BS

Job description

Global Regulatory Lead (GRL) / US Regulatory Lead (USRL) - Cardiovascular

This person will provide strategic regulatory leadership for a late-stage cardiovascular development program and serve as the primary regulatory lead for the Milvexian indication.

Key Responsibilities:

Global Regulatory Leadership

• Serve as the Global Regulatory Lead (GRL) and/or US Regulatory Lead (USRL) for a late-stage cardiovascular development program.
• Lead global regulatory strategy for the Milvexian indication, ensuring alignment with program objectives, clinical development plans, and business goals.
• Provide regulatory leadership throughout key late-stage milestones, including Database Lock (DBL), NDA preparation, submission, and review activities.
• Lead internal and joint Global Regulatory Teams (GRTs), driving effective collaboration, decision-making, and execution across partner organizations.

NDA Submission and Regulatory Strategy

• Drive preparation and regulatory readiness for the original NDA submission currently underway.
• Provide global submission leadership and oversight, ensuring:
• Integrated submission planning
• Cross-functional alignment
• Risk identification and escalation
• High-quality execution across global submission workstreams
• Develop product registration strategies and translate them into actionable operational plans.
• Create alternative regulatory pathways and risk mitigation strategies to achieve program objectives.
• Formulate U.S. regulatory strategies and oversee submission activities.

Health Authority Engagement

• Develop and execute asset-specific Global and U.S. Health Authority engagement strategies.
• Lead interactions with Health Authorities and regulatory agencies globally in partnership with regional and local regulatory teams.
• Serve as a regulatory subject matter expert, providing strategic guidance on agency communications, regulatory risks, and submission approaches.
• Support preparation of briefing documents, regulatory meeting materials, and agency responses.

Cross-Functional Collaboration

• Collaborate and influence internal stakeholders and external regulatory partners to address regulatory considerations within development plans.
• Operate effectively within a strategic partnership environment, aligning regulatory strategy, governance, decision-making, and execution plans across organizations.
• Lead resolution of critical regulatory issues by bringing together appropriate technical and regulatory experts.

Strategic Regulatory Support

• Provide strategic regulatory input to:
• Clinical Study Protocols
• Clinical Study Reports
• Nonclinical Reports and Summaries
• Clinical Summary Documents
• Statistical Analysis Plans
• NDA and other regulatory submission documents
• Contribute to the development of:
• Target Product Profiles (TPP)
• Company Core Data Sheets (CCDS)
• U.S. and global labeling strategies
• Country-specific labeling requirements

Required Qualifications

• Solid scientific background with a PhD, MD, PharmD, MS, or BS in a relevant scientific discipline.
• Significant experience in Regulatory Affairs (typically 4-7+ years).
• Prior experience serving as a:
• Global Regulatory Lead (GRL)
• U.S. Regulatory Lead (USRL)

Preferred Qualifications

• Proven success developing and implementing global regulatory strategies that support clinical development and successful product registration.
• Strong experience communicating regulatory strategy, risks, and recommendations to senior leadership and cross-functional stakeholders.
• Experience leading complex matrix teams across multiple functions and geographies.
• Demonstrated ability to translate complex scientific and regulatory issues into clear business recommendations.
• Proven success negotiating regulatory objectives with Health Authorities.