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

Location: Arlington, Baltimore, Boston, Chantilly, Charleston, Chicago, EY-Pitts, Hartford, Hoboken, McLean, New York, Philadelphia, Providence, Stamford, Washington At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. Our clients operate in a world where achieving high performance is just as important as the patients they serve. EY’s Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting their organization’s performance and impacting patient safety. The opportunity The Life Sciences Risk Consulting Services team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry. You will be an integral part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth. Our team advises clients on aligning risk and business objectives from strategy to execution, and improving coordination of risk activities across the organization for better outcomes. This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally: Quality Management Systems Regulatory Affairs Laboratory Information Management Systems Computer Systems Validation 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. The ideal candidate will have a deep understanding of the life sciences market, a proven track record in regulatory compliance, and the ability to develop and execute strategies that enhance our service offerings and client relationships. Your Key Responsibilities Your time will be spent leading client engagement teams to deliver projects in the life sciences domain, including: Strategic Growth: Drive the growth of Regulatory Submissions by identifying and capitalizing on market opportunities Market Understanding: Develop a comprehensive understanding of the life sciences regulatory landscape, including key players, trends, and competitive dynamics. Solution Development: Collaborate with internal teams to develop innovative solutions that address client needs in regulatory submissions, ensuring alignment with market demands and compliance requirements. Team Development: 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. Go-To-Market Strategy: 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. Client Engagement: 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. Practice Development: 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. You will also be expected to lead teams in consistently delivering high-quality client services by leveraging your extensive technical expertise and professional knowledge. In addition, you will be responsible for nurturing and maintaining long-term client relationships, ensuring a strategic and collaborative approach to project delivery. Skills And Attributes For Success 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. To qualify for the role you must have A bachelor’s or master’s degree in 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. Ideally, you’ll also have 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. Ability to travel domestically and internationally. Travel expectation up to 40%. What We Look For We are interested in passionate leaders with strong delivery capability, and a strong desire to stay on top of trends in the life sciences industry. If you have a strong passion for helping businesses drive measurable value while serving patients, then this role is for you. What We Offer You At EY, we’ll develop you with future-focused skills and equip you with world-class experiences. We’ll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learn more. We offer a comprehensive compensation and benefits package where you’ll be rewarded based on your performance and recognized for the value you bring to the business. 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. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options. Join us in our team-led and leader-enabled hybrid model. 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. Under our flexible vacation policy, you’ll decide how much vacation time you need based on your own personal circumstances. You’ll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being. Are you ready to shape your future with confidence? Apply today. EY accepts applications for this position on an on-going basis. For those living in California, please click here for additional information. EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities. EY | Building a better working world EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis, including arrest and conviction records, in accordance with applicable law. EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY’s Talent Shared Services Team (TSS) or email the TSS at View email address on click.appcast.io. #J-18808-Ljbffr EY