Remote Regulatory Manager — Global Clinical Submissions

Precisionmedicinegroup; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Precision Medicine Group is seeking a Regulatory Manager / Senior Regulatory Manager to join our global team in advancing regulatory strategy for clinical trials and submissions. You will coordinate regulatory documents, lead submissions to authorities, and guide cross‑functional teams to ensure compliant, timely filings.

The ideal candidate will have CRO or pharmaceutical industry experience, a scientific background, and the ability to travel domestically and internationally as needed.

Qualifications

• Bachelor's degree in a scientific field or equivalent experience.
• 5+ years regulatory experience for Manager level and 7+ years for Senior Manager level.
• Experience leading Clinical Submissions for CRO or pharmaceutical industry.
• Knowledge of EU/US regulatory milestones including INDs/CTAs and post‑approval submissions.

Responsibilities

• Provide regulatory strategy and development guidance across the clinical development life cycle.
• Coordinate and prepare regulatory submissions to authorities and ethics committees.
• Lead and coordinate regional/global regulatory teams to meet submission targets.
• Present regulatory guidance at project team meetings with internal and external stakeholders.
• Maintain regulatory plans, trackers and intelligence tools and report to Regulatory Leadership.

Skills

Regulatory strategy

Regulatory submissions

IND/CTA submissions

Team leadership

Education

Bachelor's degree in science

CRO/pharma experience

Tools

Regulatory intelligence tools

GxP compliance systems

Job description

Precision Medicine Group is seeking a Regulatory Manager / Senior Regulatory Manager to join our global team in advancing regulatory strategy for clinical trials and submissions. You will coordinate regulatory documents, lead submissions to authorities, and guide cross‑functional teams to ensure compliant, timely filings.

The ideal candidate will have CRO or pharmaceutical industry experience, a scientific background, and the ability to travel domestically and internationally as needed.