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About the Role

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.

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.
Lead teams in consistently delivering high-quality client services by leveraging extensive technical expertise and professional knowledge.
Nurture and maintain long-term client relationships, ensuring a strategic and collaborative approach to project delivery.

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.
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%.
Passionate leaders with strong delivery capability, and a strong desire to stay on top of trends in the life sciences industry.
Strong passion for helping businesses drive measurable value while serving patients.

Skills

Regulatory Submissions
Life Sciences Regulatory Landscape
Regulatory Compliance
FDA Regulatory Process
Team Management
Business Strategy Development
Analytical Skills
Problem-Solving
Communication Skills
Interpersonal Skills
Go-To-Market Strategy
Client Relationship Management
Project Management
Risk Management
Global Submissions
21 CFR
ICH Guidelines
EU Regulations
Global Regulatory Strategies
Lifecycle Management
Health Authority Interactions
Thought Leadership
Practice Development

Location

New York
Atlanta
Boston
Chicago
Dallas
Hoboken
Houston
McLean
North Carolina
Philadelphia

Work Type

Hybrid

Experience Level

Senior Manager
8+ years of Regulatory Affairs experience

Education Level

Bachelor's or Master's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred)

Salary/Compensations

Base salary range for this job in all geographic locations in the US is $138,100 to $315,600.
Base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $165,700 to $358,700.

Benefits

Medical and dental coverage
Pension and 401(k) plans
Wide range of paid time off options
Flexible vacation policy
Time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence

About the Company

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.

Equal Opportunity

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 ssc.customersupport@ey.com.