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

EY - Life Sciences Regulatory Submissions - Senior Manager

National Risk – Enterprise Risk – Reg Comp – Life Sciences – Reg Submissions – Senior Manager

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.