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

About the role

EY's Life Sciences Regulatory Submissions - Senior Manager role is pivotal in driving growth and establishing EY as a leader in the Regulatory Compliance sector, particularly in Regulatory Submissions. The role involves leading client engagement teams to deliver projects in the life sciences domain, including strategic growth, market understanding, solution development, team development, go-to-market strategy, client engagement, and practice 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, 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

• A bachelor’s or master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field, with an 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

Qualifications

• 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
• 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