Global Regulatory Leader - Clinical Submissions

Precision Medicine Group; Peapack-Gladstone (NJ); Presencial; USD 106.000 - 151.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance and disability benefits

Parental leave

Paid time off

Descripción de la vacante

Precision Medicine Group in New Jersey is seeking a Regulatory Manager to provide regulatory development guidance across the clinical development life cycle and coordinate submissions to regulatory authorities and ethics committees.

The role leads regional/global activities, mentors Regulatory Affairs staff, and contributes to regulatory strategy while staying current with ICH, GMP, and country-specific requirements.

Formación

• Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline.
• Fluent in English.
• 5+ years or more relevant regulatory affairs experience.
• Specialized knowledge of regulatory activities for at least one major region (EU, US).
• Ability to understand clinical and pre-clinical study results for regulatory positions and strategy.

Responsabilidades

• Provides regulatory guidance throughout the clinical development life cycle.
• Coordinate and prepare regulatory submissions to authorities/ethics committees.
• Lead project teams and oversee regulatory submissions targets.
• Maintain regulatory intelligence tools and project trackers.
• Contribute to regulatory strategy and timelines for new study opportunities.

Conocimientos

Regulatory affairs

Clinical development life cycle

Regulatory submissions

Project leadership

Communication

Team collaboration

Educación

Bachelor's degree or equivalent in science/healthcare

Herramientas

MS Office/Office 365

Descripción del empleo

Precision Medicine Group in New Jersey is seeking a Regulatory Manager to provide regulatory development guidance across the clinical development life cycle and coordinate submissions to regulatory authorities and ethics committees.

The role leads regional/global activities, mentors Regulatory Affairs staff, and contributes to regulatory strategy while staying current with ICH, GMP, and country-specific requirements.