Strategic Regulatory Lead - Global Trials

Precision for Medicine; 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

Disability benefits

Parental leave

Paid time off for sick leave and VAC

Job summary

Precision Medicine Group in New Jersey is seeking a Regulatory Manager to guide regulatory strategy across the clinical development lifecycle and prepare submissions for Regulatory Authorities and Ethics Committees. You will support and enhance the corporate regulatory function while coordinating with project teams.

The role requires senior regulatory expertise (EU/US), the ability to lead teams, and willingness to travel as needed.

Qualifications

• Bachelor's degree in a scientific or healthcare discipline preferred.
• 5+ years of regulatory affairs experience required.
• In-depth knowledge of drug development and regulatory milestones.

Responsibilities

• Provides regulatory guidance throughout the clinical development lifecycle.
• Coordinates and prepares submissions to Regulatory Authorities including CTA/IND and amendments.
• Develops and reviews submission documents to ensure regulatory compliance.
• Represents Global Regulatory Affairs in project team meetings with internal and external stakeholders.
• Leads or participates in regional/global regulatory projects to meet submission targets.
• Oversees Regulatory Affairs Specialists to ensure timely deliverables.
• Maintains project plans and regulatory intelligence tools; informs Regulatory Leadership.
• Mentors Regulatory staff and contributes to regulatory strategy and timelines.

Skills

Regulatory affairs

Regulatory strategy

Drug development knowledge

Clinical trials

Cross-functional collaboration

Travel (domestic/international)

Project leadership

Communication skills

Attention to detail

Team mentoring

Education

Bachelor's degree

Job description

Precision Medicine Group in New Jersey is seeking a Regulatory Manager to guide regulatory strategy across the clinical development lifecycle and prepare submissions for Regulatory Authorities and Ethics Committees. You will support and enhance the corporate regulatory function while coordinating with project teams.

The role requires senior regulatory expertise (EU/US), the ability to lead teams, and willingness to travel as needed.