Global Regulatory Strategy Director Remote

Merck; Austin (TX); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck seeks a Director (Principal Scientist) Global Regulatory Liaison to lead the development and execution of worldwide regulatory strategies for Immunology programs. As the single global point of contact, you will work with FDA/EMA and affiliates to optimize labeling and accelerate approvals.

You will independently manage complex programs, partner with Product Development Teams, and guide cross-functional regulatory teams through lifecycle submissions and strategic regulatory planning.

Qualifications

• Minimum 7 years of relevant drug development experience with majority in regulatory.
• MD/PhD/PharmD with minimum 5 years relevant drug development experience with three years in regulatory.
• Strong strategic thinking, problem-solving, and continuous learning mindset.
• Experience leading or supporting direct interactions with major Health Authorities (e.g., FDA, EMA).
• Immunology therapeutic area experience preferred.

Responsibilities

• Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies for assigned indications.
• Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling.
• Provides expert advice as Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise throughout the life cycle of the drug.
• Provides leadership to the Global Regulatory Team coordinating cross-functional regulatory support for development programs and marketed products.
• Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions; responsible for regulatory review and final approval for all submissions and associated documentation.
• Reviews and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
• Interact independently with regulatory agencies (FDA, EMA), including leading meetings, teleconferences, and written communications.
• Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.
• Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures.
• Prepares IND/CTAs for global studies related to investigational drugs/biologics.
• Participates in regulatory due diligence activities for licensing candidate reviews.

Skills

Drug Development

Global Regulatory

Regulatory Affairs

Regulatory Submissions

Strategic Leadership

Education

Bachelor’s or Master’s degree

MD/PhD/PharmD

Job description

Merck seeks a Director (Principal Scientist) Global Regulatory Liaison to lead the development and execution of worldwide regulatory strategies for Immunology programs. As the single global point of contact, you will work with FDA/EMA and affiliates to optimize labeling and accelerate approvals.

You will independently manage complex programs, partner with Product Development Teams, and guide cross-functional regulatory teams through lifecycle submissions and strategic regulatory planning.