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

EY•Atlanta, GA

110d•$138,100 - $358,700•Hybrid

About The Position

EY is seeking a Senior Manager to lead its Life Sciences Regulatory Submissions practice within Risk Consulting – Enterprise Risk. The role supports biotechnology, pharmaceutical, medical device, and medical technology clients in identifying, managing, and responding to risks while maintaining growth and patient safety. The broader team advises clients on aligning risk and business objectives and developing processes and systems for areas governed by the FDA and comparable global regulators, including quality management systems, regulatory affairs, laboratory information management systems, and computer systems validation. The Senior Manager will lead client engagement teams and drive the growth and development of the Regulatory Submissions practice. Responsibilities include understanding the market and regulatory landscape, developing client-focused solutions, assessing and developing team capabilities, contributing to go-to-market strategy, and building client relationships, including in high-stakes FDA submission matters. The role also involves expanding the practice’s service offerings and capabilities, hiring and developing the team, and driving operational excellence. The Senior Manager is expected to provide high-quality client services, apply extensive technical expertise, and maintain long-term, collaborative client relationships. This is a hybrid, client-serving role. EY expects most external client-serving employees to work together in person 40–60% of the time over the course of an engagement, project, or year. Travel may be domestic and international, with an expectation of up to 40%.

Requirements

Bachelor’s or master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field; an advanced degree is preferred.
At least 8 years of Regulatory Affairs experience, with a strong focus on regulatory submissions in the life sciences industry.
Demonstrated experience leading major global submissions to the FDA and at least one other major health authority.
Strong working knowledge of applicable regulations, such as 21 CFR, ICH guidelines, and 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.
Proven experience in life sciences regulatory compliance, focused on regulatory submissions.
Strong understanding of the FDA regulatory process and its risks and challenges.
Demonstrated ability to drive revenue growth and develop successful business strategies.
Leadership and team management skills, with a track record of building high-performing teams.
Strong analytical and problem-solving skills, including translating market insights into actionable strategies.
Exceptional communication and interpersonal skills, including the ability to engage and influence senior stakeholders.

Nice To Haves

Proven experience managing teams and complex, cross-functional initiatives.
Excellent written and verbal communication skills and ability to engage senior stakeholders.
Experience in a consulting, CRO, or matrixed corporate environment.
Ability to travel domestically and internationally.

Responsibilities

Lead client engagement teams delivering life sciences projects, including regulatory submissions work.
Drive practice growth by identifying and capitalizing on market opportunities.
Develop an understanding of the life sciences regulatory landscape, including key players, trends, and competitive dynamics.
Collaborate with internal teams to develop innovative regulatory submission solutions aligned with client needs, market demands, and compliance requirements.
Assess and validate team skillsets and foster continuous improvement and professional development.
Work with leadership to develop and execute a go-to-market strategy that communicates EY’s value proposition.
Engage clients to understand their challenges and position EY as a trusted advisor.
Build and maintain relationships with client stakeholders, particularly in high-stakes regulatory submission matters involving the FDA.
Build out the Regulatory Compliance practice by identifying service offerings, enhancing capabilities, hiring the team, and driving operational excellence.
Lead teams in consistently delivering high-quality client services using technical expertise and professional knowledge.
Nurture long-term client relationships and support strategic, collaborative project delivery.

Benefits

Medical coverage
Dental coverage
Pension plans
401(k) plans
Paid time off options
Flexible vacation policy
EY Paid Holidays
Winter and Summer breaks
Personal and Family Care time off
Other leaves of absence to support physical, financial, and emotional well-being