Risk Consulting - Enterprise Risk - Sr Manager - Life Sciences - Regulatory Affairs
EY Stamford, CT Full-time 3/24/2026
Master's with 2+ Years of Experience
Approval 97.9%•Total filings 747•New hires 303•
💎 Strong Sponsor
•FY 2025Job Description
EY is seeking a Senior Manager to lead its Life Sciences Regulatory Submissions practice, focusing on driving growth and establishing EY as a leader in Regulatory Compliance. The role requires a deep understanding of the life sciences market and regulatory compliance, along with the ability to develop strategies that enhance service offerings and client relationships.
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
Responsibilities
- 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
- Work with leadership in the development and execution of a robust go-to-market strategy
- Build and maintain strong relationships with key stakeholders in client organizations
- Play a key role in building out the Regulatory Compliance practice, including identifying new service offerings and enhancing existing capabilities
Benefits
- Ernst & Young (EY) offers a comprehensive and competitive benefits package designed to support the well-being of its employees across various dimensions.
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