The Senior Manager in Life Sciences Regulatory Affairs at EY will lead the Regulatory Submissions practice, focusing on helping clients in the life sciences sector manage regulatory compliance and enhance their service offerings. This role is crucial for driving growth and establishing EY as a leader in the Regulatory Compliance sector. The team advises clients on aligning risk and business objectives while ensuring compliance with regulatory requirements. The ideal candidate will possess a deep understanding of the life sciences market and a proven track record in regulatory compliance.

• A bachelor’s or master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
• 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.

• Lead client engagement teams to deliver projects in the life sciences domain.
• Drive the growth of Regulatory Submissions by identifying and capitalizing on market opportunities.
• Develop a comprehensive understanding of the life sciences regulatory landscape.
• Collaborate with internal teams to develop innovative solutions for regulatory submissions.
• Assess and validate the skillsets of the team to ensure high-quality service delivery.
• Build and maintain strong relationships with key stakeholders in client organizations.

• Ernst & Young (EY) offers a comprehensive and competitive benefits package designed to support the well-being of its employees across various dimensions.