Global Regulatory Manager - Remote Submissions & Strategy

Precision Medicine Group; United States; Remote; USD 106,000 - 151,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement savings benefits

Paid time off

Job summary

Precision Medicine Group is seeking a Regulatory Manager to provide regulatory development guidance across the clinical development life cycle. You will coordinate submissions to Regulatory Authorities and Ethics Committees, and ensure high-quality, compliant regulatory documentation while supporting the global Regulatory function.

Ideal candidates have 5+ years of regulatory affairs experience, strong knowledge of EU/US regulatory activities, and the ability to lead teams and travel as needed.

Qualifications

• Bachelor's degree or equivalent in a scientific/healthcare discipline.
• 5+ years regulatory affairs experience.
• Knowledge of EU and US regulatory processes including IND/CTA submissions.
• Willingness to travel domestically and internationally.
• Fluent in English.

Responsibilities

• Provide regulatory guidance throughout the clinical development life cycle.
• Coordinate and prepare submissions to Regulatory Authorities and Ethics Committees.
• Develop and review documents for regulatory submissions to ensure compliance.
• Represent Global Regulatory Affairs in project team meetings.
• Oversee Regulatory Affairs team to meet submission targets.
• Maintain project plans and regulatory intelligence tools.

Skills

Regulatory affairs

Clinical development

Regulatory submissions

Project coordination

Team leadership

Education

Bachelor's degree in science/healthcare

Tools

MS Office/Office 365

Job description

Precision Medicine Group is seeking a Regulatory Manager to provide regulatory development guidance across the clinical development life cycle. You will coordinate submissions to Regulatory Authorities and Ethics Committees, and ensure high-quality, compliant regulatory documentation while supporting the global Regulatory function.

Ideal candidates have 5+ years of regulatory affairs experience, strong knowledge of EU/US regulatory activities, and the ability to lead teams and travel as needed.