Senior Manager - Life Sciences Risk Consulting - ...

At EY, we are dedicated to helping you shape your future with confidence! Join our globally connected powerhouse and take your career to new heights. As part of EY, you will contribute to our mission of building a better working world. The Life Sciences team at EY plays a crucial role in advising clients in the biotechnology, pharmaceutical, medical device, and medical technology industries. We assist them in making strategic decisions to mitigate risks that impact their performance and patient safety. The Opportunity As a Senior Manager within our Life Sciences Risk Consulting Services team, you will help clients navigate the complex landscape of regulatory compliance. You will focus on: Quality Management Systems Regulatory Affairs Laboratory Information Management Systems Computer Systems Validation This key leadership role involves overseeing EY's Life Sciences Regulatory Submissions practice to drive growth and establish market leadership in Regulatory Compliance. Your deep understanding of the life sciences market, regulatory compliance expertise, and strategic insight will be vital in enhancing our service offerings and client relationships. Your Key Responsibilities Strategic Growth: Identify and exploit opportunities to grow our regulatory submissions service. Market Understanding: Develop insights into the life sciences regulatory landscape, including key players and trends. Solution Development: Collaborate across teams to create innovative solutions addressing client needs in regulatory submissions. Team Development: Ensure the team possesses the necessary skills for high-quality service delivery and foster continuous improvement. Go-To-Market Strategy: Create and implement effective strategies that communicate EY’s value proposition to clients. Client Engagement: Build strong relationships with stakeholders, particularly during critical regulatory submission processes. Practice Development: Identify new service offerings, improve capabilities, and drive operational excellence within the practice. You will lead teams in delivering exceptional client services by leveraging your expertise, while also nurturing long-term client relationships with a strategic and collaborative approach. Skills and Attributes for Success Extensive experience in regulatory compliance in the life sciences sector, particularly regulatory submissions. Strong grasp of the FDA regulatory process and related risks. Proven track record in driving revenue growth and formulating successful business strategies. Excellent leadership and team development capabilities. Strong analytical prowess with the ability to derive actionable strategies from market insights. Exceptional communication skills to engage and influence senior stakeholders. To Qualify for the Role You Must Have 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 focused on life sciences. Experience leading significant global submissions (FDA and at least one other major health authority). Solid knowledge of applicable regulations (21 CFR, ICH guidelines, EU regulations). Experience in global regulatory strategies and lifecycle management. Strong project and risk management skills. Experience with inspections, health authority interactions, and regulatory inquiries. Ability to contribute to go-to-market strategies and practice development initiatives. Ideally, You'll Also Have Experience managing teams and complex, cross-functional initiatives. Excellent communication skills to engage senior stakeholders. Experience in consulting, CRO, or matrixed corporate environments preferred. Willingness to travel domestically and internationally, with travel expectations of up to 40%. What We Look For We seek passionate leaders committed to delivering impactful results while keeping abreast of industry trends. If you are eager to drive measurable value for businesses and contribute toward patient care, this role is for you! What We Offer You At EY, you will develop future-focused skills and gain world-class experience. Enjoy a flexible work environment that nurtures diversity and inclusion. Our comprehensive compensation package rewards your performance with recognition for the value you bring. This role offers a competitive base salary range between $138,100 to $315,600 in the US, with potential variations depending on location, education, and experience. Join us in our hybrid model, where collaboration occurs in person 40-60% of the time during engagements. Take advantage of our flexible vacation policy, allowing you to determine your own vacation needs while also providing for designated holidays and necessary leave. Ready to shape your future with confidence? Apply today! We welcome applications on an ongoing basis. At EY, we uphold high ethical standards and seek candidates who demonstrate these values. EY | Building a Better Working World

Created: 2026-03-04