Join EY's GDS Consulting team as a Senior Manager in Regulatory Compliance, focusing on Regulatory Affairs. This role is crucial for driving regulatory strategy and IT transformation within regulated GxP environments. You'll work with global clients, leveraging deep industry knowledge and consulting skills to deliver compliant, scalable solutions.

As a leader, you will establish and strengthen relationships, ensuring high-quality deliverables and operational efficiency. We are seeking an experienced professional passionate about excelling in a highly regulated sector and committed to building a better working world.

Lead global regulatory strategy, ensuring compliance with health authorities like FDA, EMA, and MHRA. Provide expert guidance on submissions and lifecycle management. Drive RIMS implementation and optimization to enhance data integrity and efficiency. Design regulatory roadmaps, support health authority interactions, and identify opportunities for process standardization and digital enablement.

Build strong internal relationships and engage with client stakeholders to propose innovative digital solutions in the RA space. Contribute to business development, proposals, and thought leadership while staying current with evolving regulatory requirements.

Requires 8-12 years of hands-on experience in regulatory affairs, with a preference for Veeva Vault RIMS or similar platforms. Proven experience in regulatory affairs and RIMS implementation or management is essential.

Strong interpersonal, written, and presentation skills are vital. Experience in managing teams and delivering complex regulatory programs is expected. Ideal candidates will have experience in managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations, coupled with team management and solution design capabilities.