Global Regulatory Leader - Clinical Submissions

Precision Medicine Group; Peapack-Gladstone (NJ); On-site; USD 106,000 - 151,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance and disability benefits

Parental leave

Paid time off

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

Clinical development life cycle

Regulatory submissions

Project leadership

Communication

Team collaboration

Education

Bachelor's degree or equivalent in science/healthcare

Tools

MS Office/Office 365

Job description

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.