develop and implement regulatory strategies for assigned programs in collaboration with global development teams
lead the preparation and submission of Clinical Trial Applications (CTAs) via the Clinical Trials Information System (CTIS) to multiple EU member states
lead regulatory activities such as CTA amendments, annual reports, and other key submissions
conduct critical analyses of clinical and preclinical data, providing interpretations and conclusions to guide decision-making
review clinical protocols and study reports to ensure alignment with EU regulatory requirements
lead the preparation and execution of EU Scientific Advice requests, including meetings with the European Medicines Agency (EMA) and other national agencies
stay ahead of the curve by monitoring and interpreting new EU Commission and EMA guidelines, and provide training to scientific staff as needed
represent Regeneron in interactions with external stakeholders, including EMA scientific committees, EU national agencies, and industry associations
Requirements
minimum of 4+ years of regulatory experience focused on supporting products through clinical development
advanced degree in a scientific field is required
experience with the EMA (e.g., scientific advice, orphan designation, Pediatric Investigation Plans) is highly preferred
consistent record of supporting EU Clinical Trial Applications through approval and study start-up is crucial
preferred qualifications include experience in regulatory strategy for metabolism or ophthalmology programs, as well as marketing authorization applications or lifecycle management of approved products via the centralized procedure
strong written and verbal communication skills, along with the ability to negotiate and clearly articulate positions to partners
Benefits
health and wellness programs (including medical, dental, vision, life, and disability insurance)
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