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

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

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

Senior Manager, Enterprise Risk – Life Sciences, Regulatory Affairs

Key skills