Quality & Compliance Manager developing compliance and quality management systems at HESS Cash Systems. Responsible for internal audits, risk management, and ISO certification preparation.
EY
Hybrid Senior Manager, Enterprise Risk – Life Sciences, Regulatory Affairs
Posted 50 minutes ago
About the role
- Senior Manager leading the Regulatory Submissions practice at EY, focusing on the Life Sciences sector. Driving growth and compliance strategies while managing client relationships and team development.
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 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
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