Global Cardiovascular Regulatory Lead | NDA Strategy

Medasource; New Jersey; Vor Ort; USD 150.000 - 210.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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).

Aufgaben

• 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.

Kenntnisse

Regulatory leadership

Cross-functional communication

Strategic thinking

Stakeholder management

Ausbildung

PhD

MD

PharmD

MS

BS

Jobbeschreibung

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.