Global Regulatory Affairs Manager

Precision Medicine Group; United States; À distance; USD 110 000 - 160 000; Plein temps

Résumé du poste

Precision for Medicine is seeking a Regulatory Manager / Senior Regulatory Manager to lead regulatory strategy for clinical trials and submissions, with global scope.

You will coordinate CTA/IND submissions, orphan designations, paediatric planning, and regulatory agency meetings, and mentor Regulatory Affairs staff.

This remote US role offers travel as needed and opportunities to influence development programs across oncology and rare diseases.

Qualifications

• Bachelor's degree in science or healthcare field.
• 5+ years regulatory experience for Manager and 7+ years for Senior Manager.
• Experience in CRO or pharmaceutical industry with leading clinical submissions.
• Strong knowledge of regulatory milestones across major regions (EU, US).

Responsabilités

• Provide regulatory strategy throughout the clinical development life cycle.
• Coordinate CTA/IND submissions and regulatory authority meetings.
• Develop and review documents for submission to authorities and ethics committees.
• Lead regional or global regulatory affairs projects and timelines.
• Mentor Regulatory Affairs staff and oversee submission trackers and intelligence tools.

Connaissances

Regulatory strategy

Regulatory submissions

Clinical development

Regulatory leadership

Global regulatory affairs

US/EU regulatory

Formation

Bachelor's degree in science/healthcare

Description du poste

Precision for Medicine is seeking a Regulatory Manager / Senior Regulatory Manager to lead regulatory strategy for clinical trials and submissions, with global scope.

You will coordinate CTA/IND submissions, orphan designations, paediatric planning, and regulatory agency meetings, and mentor Regulatory Affairs staff.

This remote US role offers travel as needed and opportunities to influence development programs across oncology and rare diseases.