Hybrid Senior Manager, Regulatory Affairs

Posted last week

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About the role

  • 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

Senior Manager, Regulatory Affairs

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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