Risk Consulting - Enterprise Risk - Sr Manager - Life Sciences - Regulatory Affairs

Risk Consulting - Enterprise Risk - Sr Manager - Life Sciences - Regulatory Affairs

Location:

New York, Arlington, Baltimore, Boston, Chantilly, Charleston, Chicago, EY-Pitts, Hartford, Hoboken, McLean, New York, Philadelphia, Providence, Stamford, Washington

Date:
Feb 11, 2026

Requisition

The Life Sciences Risk Consulting Services team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry. You will be an integral part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth. Our team advises clients on aligning risk and business objectives from strategy to execution, and improving coordination of risk activities across the organization for better outcomes.

This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally:

• Quality Management Systems
• Regulatory Affairs
• Laboratory Information Management Systems
• Computer Systems Validation

EY is seeking a dynamic and experienced Senior Manager to lead EY’s Life Sciences Regulatory Submissions practice. This role is pivotal in driving growth and establishing EY as a leader in the Regulatory Compliance sector, particularly in Regulatory Submissions. The ideal candidate will have a deep understanding of the life sciences market, a proven track record in regulatory compliance, and the ability to develop and execute strategies that enhance our service offerings and client relationships.

• Strategic Growth: Drive the growth of Regulatory Submissions by identifying and capitalizing on market opportunities.
• Market Understanding: Develop a comprehensive understanding of the life sciences regulatory landscape, including key players, trends, and competitive dynamics.
• Solution Development: Collaborate with internal teams to develop innovative solutions that address client needs in regulatory submissions, ensuring alignment with market demands and compliance requirements.
• Team Development: Assess and validate the skillsets of the team, ensuring that the practice is equipped with the necessary expertise to deliver high-quality services. Foster a culture of continuous improvement and professional development.
• Go-To-Market Strategy: Work with leadership in the development and execution of a robust go-to-market (GTM) strategy that effectively communicates EY's value proposition to clients. Engage with clients to understand their challenges and position EY as a trusted advisor.
• Client Engagement: Build and maintain strong relationships with key stakeholders in client organizations, particularly in high-stakes regulatory submission scenarios involving the FDA. Ensure that clients respect and value EY's insights and recommendations.
• Practice Development: Play a key role in building out the Regulatory Compliance practice, including identifying new service offerings, enhancing existing capabilities, hiring the team, and driving operational excellence.

• Proven experience in regulatory compliance within the life sciences sector, with a focus on regulatory submissions.
• Strong understanding of the FDA regulatory process and the associated risks and challenges.
• Demonstrated ability to drive revenue growth and develop successful business strategies.
• Excellent leadership and team management skills, with a track record of building high-performing teams.
• Strong analytical and problem-solving skills, with the ability to translate market insights into actionable strategies.
• Exceptional communication and interpersonal skills, with the ability to engage and influence senior stakeholders.

• 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).
• Stron…