Remote Global Regulatory Strategy Lead - Immunology

Merck; Montpelier (VT); Teletrabalho; USD 173 000 - 273 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation days

Sick days

Resumo da oferta

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. You will serve as the global point of contact for development teams, coordinating with agencies like FDA/EMA to optimize labeling and accelerate approvals.

The role requires independent project management, strategic thinking, and leadership of the Global Regulatory Team across multiple indications and external partners.

Qualificações

• Minimum education: B.S. or M.S. with 7+ years in drug development, regulatory focus.
• MD/PhD/PharmD with 5+ years in drug development, 3+ years in regulatory roles.

Responsabilidades

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Lead global regulatory efforts and provide single-point contact for projects.
• Coordinate submissions, reviews, and communications with global agencies (FDA/EMA).
• Lead/regulate cross-functional regulatory teams through development and life-cycle.
• Review and approve local registration study protocols for marketing authorizations.

Conhecimentos

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Formação académica

B.S. or M.S. in relevant drug development

M.D. or PhD/PharmD with regulatory experience

Descrição da oferta de emprego

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. You will serve as the global point of contact for development teams, coordinating with agencies like FDA/EMA to optimize labeling and accelerate approvals.

The role requires independent project management, strategic thinking, and leadership of the Global Regulatory Team across multiple indications and external partners.