FDA Regulatory Expert

Medpace, Inc.

266d

About The Position

Our clinical and regulatory activities are growing, and we are currently seeking a full-time FDA Regulatory Strategist to join our team. This position is responsible for the interactions with FDA, accountable for the development and implementation of the regulatory strategy for specific Sponsor projects and ensuring that the strategy is designed to deliver a rapid approval. We are seeking a strategic leader with experience in North American (US FDA) regulatory science, and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to influence cross-functional discussions with Sponsors and relevant stakeholders.

Requirements

• MD, PhD in Life Sciences, or other advanced degree.
• Minimum of 5 years of experience or equivalent of regulatory drug development.
• Expert knowledge of regulatory affairs within one or more therapeutic areas.
• Professional experience working at the FDA such as Medical Reviewer, Clinical Team Leader, or Division Director, preferred.

Responsibilities

• Provide expert regulatory strategy to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures, and agency precedent.
• Advise sponsors and project teams regarding the development and implementation of regulatory strategy throughout the clinical development processes.
• Collaborate with cross-functional teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables.

Benefits

• Flexible work environment
• Competitive PTO packages – starting at 20+ days
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Competitive compensation and benefits package
• Structured career paths with opportunities for professional growth
• Discounts for local businesses

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees