Job Overview
Location
Remote - Ireland
Job Type
Full-time
Category
Product Management
Date Posted
June 23, 2026
Full Job Description
đź“‹ Description
- • Lead risk-based audit strategy programs across therapeutic areas and studies to ensure compliance with global regulatory standards.
- • Drive strategic audit planning by leveraging risk indicators provided by study teams and global development functions.
- • Ensure all audit activities are aligned with approved audit programs and adhere to established timelines and milestones.
- • Manage audit outcomes to identify systemic trends, assess risk exposure, and communicate findings to Global Development leadership.
- • Represent Global Development Quality Assurance on complex cross-functional initiatives involving clinical operations, data management, and regulatory affairs.
- • Deliver comprehensive audit reports and performance metrics to senior leadership to inform decision-making and strategic planning.
- • Collaborate effectively with internal stakeholders across global functions, including clinical, regulatory, and operations teams, to align audit objectives with organizational priorities.
- • Navigate ambiguity and prioritize multiple high-complexity activities in a fast-paced, science-driven environment.
- • Support and participate in regulatory inspections by regulatory authorities such as the FDA, EMA, and other global agencies.
- • Maintain up-to-date knowledge of FDA, EU, and ICH GCP regulations and guidance to ensure audit practices remain compliant and current.
- • Contribute to continuous improvement of audit methodologies and quality assurance frameworks within Global Development.
- • Travel up to 10-20% as required to support on-site audit activities, inspections, or stakeholder meetings.
🎯 Requirements
- • Bachelor’s degree with 8+ years of relevant industry experience
- • 5+ years of GCP audit strategy or audit experience
- • Knowledge of FDA, EU, and ICH GCP regulations and guidance
- • Experience supporting or participating in regulatory inspections
- • Strong project management and stakeholder management capabilities
- • Excellent written and verbal communication skills with senior audiences
🏖️ Benefits
- • Annual bonuses or other incentive plans
- • Equity awards
- • Pension or retirement benefits
- • 401(k) company match
- • Health and wellness programs, including fitness centers
- • Paid time off and family support benefits
Skills & Technologies
See exactly how your profile matches this role — strengths, skill gaps, and what to do about them.
About Regeneron Pharmaceuticals, Inc.
Regeneron Pharmaceuticals, Inc. is a biotechnology company that develops, manufactures and markets antibody-based medicines for ophthalmology, oncology, immunology, infectious disease and rare disorders. Founded in 1988 and headquartered in Tarrytown, New York, Regeneron uses its proprietary VelociSuite technologies to discover fully human monoclonal antibodies and other therapeutic proteins. Its FDA-approved products include EYLEA, Dupixent, Libtayo, Praluent and Kevzara, while a broad pipeline addresses asthma, cancer, Ebola, COVID-19 and other diseases. The company operates research, manufacturing and clinical facilities across the United States and collaborates with Sanofi, Bayer and other partners worldwide.
Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.
Newsletter
Weekly remote jobs and featured talent.
No spam. Only curated remote roles and product updates. You can unsubscribe anytime.
Similar Opportunities
PermitFlow Inc.
1 month ago
Apply Digital Corporation
1 month ago