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

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

Skills

• 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 senior stakeholders