Remote Regulatory Affairs Lead for Global Trials

Precision for Medicine; Oregon; Hybrid; USD 106.000 - 151.000; Vollzeit

Benefits dieser Stelle

Discretionary annual bonus

Health insurance

Retirement savings

Life insurance

Disability benefits

Parental leave

Paid time off

Zusammenfassung

Precision Medicine Group is seeking a Regulatory Manager to provide regulatory development guidance for clinical trials and ensure timely, compliant submissions to regulatory authorities and ethics committees. The role involves coordinating documentation, leading regional or global projects, and maintaining regulatory intelligence to support the corporate function.

Domestic and international travel is required.

Qualifikationen

• Bachelor's degree or higher in a science/healthcare field; regulatory experience preferred.
• Fluent in English and proficient with regulatory documentation workflows.
• Experience with EU/US regulatory submissions and GCP guidance is a plus.

Aufgaben

• Provides regulatory development advice throughout the clinical development life cycle.
• Compiles, coordinates and reviews applications to regulatory authorities and ethics committees.
• Develops and reviews documents for regulatory submission and supports regulatory strategy.
• Represents Global Regulatory Affairs at project team meetings with internal and external customers.
• Oversees and coordinates regulatory affairs activities to meet submission targets.
• Maintains project plans, trackers and regulatory intelligence tools.

Kenntnisse

Regulatory affairs

Clinical development lifecycle

Regulatory submissions

Project coordination

Team leadership

Ausbildung

Bachelor's degree or equivalent

Graduate degree preferred

Tools

MS Office/Office 365

Jobbeschreibung

Precision Medicine Group is seeking a Regulatory Manager to provide regulatory development guidance for clinical trials and ensure timely, compliant submissions to regulatory authorities and ethics committees. The role involves coordinating documentation, leading regional or global projects, and maintaining regulatory intelligence to support the corporate function.

Domestic and international travel is required.