Global Regulatory Lead: Cardiovascular Medicine

Merck; North Wales (Montgomery County); Hybride; USD 191 000 - 300 000; Plein temps

Résumé du poste

Merck in Rahway, NJ seeks a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs focused on cardiovascular metabolic areas. You will ensure optimal labeling and the fastest time to approval by engaging with FDA and other agencies across multiple indications.

This role requires a track record of leading global regulatory teams, strategic oversight across regions, and the ability to navigate complex regulatory environments with

Qualifications

• Degree in biological science or related discipline.
• Regulatory affairs experience across multiple programs and life cycles.
• Strong leadership and team-building abilities.

Responsabilités

• Develop worldwide regulatory strategy for General Medicine programs.
• Lead Global Regulatory Team and interact with FDA and other agencies.
• Coordinate regulatory submissions and labeling to optimize time to approval.
• Provide strategic regulatory oversight across regions and indications.
• Review study protocols and marketing applications for regulatory readiness.

Connaissances

Regulatory Affairs

Drug Development

Regulatory Strategy

Written Communication

Product Approvals

Regulatory Compliance

Regulatory Leadership

Formation

BS/MS/MD/PharmD in relevant field

Description du poste

Merck in Rahway, NJ seeks a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs focused on cardiovascular metabolic areas. You will ensure optimal labeling and the fastest time to approval by engaging with FDA and other agencies across multiple indications.

This role requires a track record of leading global regulatory teams, strategic oversight across regions, and the ability to navigate complex regulatory environments with