Global Regulatory Strategy Lead (Immunology)

Merck; Lincoln (NE); A distancia; USD 173.000 - 273.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Dental benefits

Vision benefits

401(k)

Paid holidays

Vacation days

Sick days

Descripción de la vacante

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to shape worldwide regulatory strategies for Immunology programs and to drive fastest possible approval timelines. You will interact with agencies like FDA/EMA and lead cross-functional teams across development and marketing through the product lifecycle.

You will coordinate regulatory submissions globally, oversee study protocols for regulatory clearance, and mentor teams in a fast-paced, scientifically rigorous

Formación

• B.S. or M.S. with 7+ years drug development experience, regulatory focus.
• M.D. or PhD/PharmD with 5+ years drug development experience, regulatory focus.

Responsabilidades

• Develop worldwide regulatory strategies to optimize labeling and speed approvals.
• Lead global regulatory team and coordinate with agencies and affiliates.
• Prepare and oversee submissions and regulatory communications.

Conocimientos

Drug Development

Global Regulatory

Regulatory Strategy

Regulatory Submissions

Leadership

Cross-functional Leadership

Educación

B.S./M.S. in related field

M.D./PhD/PharmD with regulatory experience

Herramientas

FDA/EMA interactions

Descripción del empleo

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to shape worldwide regulatory strategies for Immunology programs and to drive fastest possible approval timelines. You will interact with agencies like FDA/EMA and lead cross-functional teams across development and marketing through the product lifecycle.

You will coordinate regulatory submissions globally, oversee study protocols for regulatory clearance, and mentor teams in a fast-paced, scientifically rigorous