EY

Senior Manager, Enterprise Risk – Life Sciences, Regulatory Affairs

EY

full-time

Posted on:

Location Type: Hybrid

Location: New York City • New York • United States

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Salary

💰 $138,100 - $315,600 per year

Job Level

Senior

About the role

  • Drive the growth of Regulatory Submissions by identifying and capitalizing on market opportunities
  • Develop a comprehensive understanding of the life sciences regulatory landscape, including key players, trends, and competitive dynamics
  • Collaborate with internal teams to develop innovative solutions that address client needs in regulatory submissions
  • Assess and validate the skillsets of the team, ensuring that the practice is equipped with the necessary expertise to deliver high-quality services
  • Work with leadership in the development and execution of a robust go-to-market (GTM) strategy
  • Build and maintain strong relationships with key stakeholders in client organizations

Requirements

  • A bachelor’s or master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred)
  • 8+ years of Regulatory Affairs experience with a strong focus on regulatory submissions in the life sciences industry
  • Demonstrated experience leading major global submissions (FDA and at least one other major health authority)
  • Strong working knowledge of applicable regulations (e.g., 21 CFR, ICH guidelines, EU regulations)
  • Experience with global regulatory strategies and lifecycle management
  • Strong project management and risk management capabilities
  • Prior experience supporting inspections, health authority interactions, or regulatory inquiries
  • Ability to contribute to go-to-market strategies, thought leadership, or practice development initiatives
Benefits
  • Medical and dental coverage
  • Pension and 401(k) plans
  • Wide range of paid time off options
  • Flexible vacation policy
  • Time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Regulatory AffairsRegulatory SubmissionsGlobal SubmissionsProject ManagementRisk ManagementRegulatory StrategiesLifecycle ManagementFDA Regulations21 CFRICH Guidelines
Soft Skills
CollaborationLeadershipRelationship BuildingClient Needs AssessmentInnovative Solutions DevelopmentMarket Opportunity IdentificationTeam Skillset AssessmentThought LeadershipPractice DevelopmentCommunication