Specialist II in Regulatory Affairs preparing and maintaining global submissions for conducting clinical investigations. Collaborating with engineering and regulatory teams to ensure compliance with worldwide regulations.
About the role
- Senior Manager, Regulatory Affairs at Regeneron developing regulatory strategies for innovative programs in metabolism and ophthalmology. Collaborating with global teams on compliance and submissions.
Responsibilities
- 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)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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