Remote Global Regulatory Lead - Immunology

Merck; Augusta (ME); Remoto; USD 173.000 - 273.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision

401(k) retirement

Paid holidays

Vacation

Sick days

Descrizione del lavoro

Merck in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs and oversee labeling optimization to accelerate approvals.

You will manage global regulatory programs, interact with FDA/EMA, lead cross-functional teams, and coordinate submissions and regulatory reviews across markets; immunology experience preferred. This role offers leadership responsibility and a comprehensive benefits package.

Competenze

• BS or MS with a minimum of 7 years of relevant drug development experience with majority in regulatory.
• MD or PhD/PharmD with a minimum of 5 years relevant drug development experience with three years in regulatory.
• Experience interacting with major Health Authorities (FDA, EMA).

Mansioni

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Coordinating submissions and regulatory interactions for global programs.
• Provides leadership to cross-functional Regulatory teams.

Conoscenze

Drug Development

Global Regulatory

Regulatory Affairs Management

Regulatory Submissions

Strategic Leadership

Effective Communication

Formazione

BS/MS in life sciences

MD/PhD/PharmD with regulatory experience

Descrizione del lavoro

Merck in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs and oversee labeling optimization to accelerate approvals.

You will manage global regulatory programs, interact with FDA/EMA, lead cross-functional teams, and coordinate submissions and regulatory reviews across markets; immunology experience preferred. This role offers leadership responsibility and a comprehensive benefits package.