Global Regulatory Affairs Lead — Clinical Trials

Precision Medicine Group; Northern (KY); Hybrid; USD 106,000 - 151,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a Regulatory Manager to provide regulatory development guidance for clinical trials, ensuring timely, quality submissions in compliance with regulations.

You will coordinate documents for Regulatory Authorities and Ethics Committees, support corporate Regulatory function, and lead regional or global regulatory activities while traveling domestically and internationally as needed. Strong communication and leadership are essential.

Qualifications

• 5+ years regulatory affairs experience
• Knowledge of EU/US regulatory submissions (IND/CTA, amendments)
• Ability to travel domestically and internationally
• Understanding of drug development process and regulatory milestones
• Knowledge of ICH GCP guidance and clinical trials methodology

Responsibilities

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including CTA/IND, annual reports and amendments
• Develops and/or reviews documents for submission to Regulatory Authorities and Ethics Committees
• Represents Global Regulatory Affairs at project team meetings
• Leads projects for the region or globally as needed
• Oversees Regulatory Affairs Specialists to meet submission targets
• Maintains project plans, trackers and regulatory intelligence tools
• Contributes to regulatory strategy and timelines for new study opportunities
• Maintains company standards for submitted information
• Participates in corporate quality initiatives across units
• Keeps up-to-date with laws and guidelines governing drug development
• Provides ICH GCP guidance to internal and external clients
• Represents Global Regulatory Affairs at business development meetings

Skills

regulatory affairs

project management

stakeholder communication

travel readiness

Education

Bachelor's degree

Job description

Precision Medicine Group is seeking a Regulatory Manager to provide regulatory development guidance for clinical trials, ensuring timely, quality submissions in compliance with regulations.

You will coordinate documents for Regulatory Authorities and Ethics Committees, support corporate Regulatory function, and lead regional or global regulatory activities while traveling domestically and internationally as needed. Strong communication and leadership are essential.