Risk Consulting - Enterprise Risk - Sr Manager - Life Sciences - Regulatory Affairs
About the role
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.
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, ensuring alignment with market demands and compliance requirements
- 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
- 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
- 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
- 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
Requirements
- 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
Qualifications
- A bachelor’s or master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field 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
Skills and Attributes for Success
- Proven experience managing teams and complex, cross-functional initiatives
- Excellent written and verbal communication skills, with the ability to engage senior stakeholders
- Experience working in a consulting, CRO, or matrixed corporate environment preferred
Benefits
The base salary range for this job in all geographic locations in the US is $138,100 to $315,600. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $165,700 to $358,700. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography.
Pay
The base salary range for this job in all geographic locations in the US is $138,100 to $315,600. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $165,700 to $358,700. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography.
Schedule
Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year.