Join EY's Regulatory Compliance team and make a significant impact by understanding client business needs and delivering tailored solutions.

This role is central to establishing and strengthening relationships, both internally and externally. You'll drive projects to successful completion with a focus on high-quality deliverables and operational efficiency, proactively identifying and communicating risks to stakeholders.

We are looking for a seasoned Manager with extensive expertise in Regulatory Affairs to lead strategic initiatives and IT-enabled transformations within regulated GxP environments. Your strong consulting skills and industry knowledge will be key to translating regulatory strategy into scalable, compliant solutions for a global clientele. This is an opportunity to build a better working world through impactful regulatory guidance.

Lead the development of global regulatory strategies, ensuring adherence to health authority guidelines such as FDA, EMA, MHRA, and PMDA.

Provide expert advice on regulatory submissions, dossier preparation, and lifecycle management across various markets. Drive the implementation and optimization of RIMS, like Veeva Vault RIM, to enhance data integrity and efficiency.

Design regulatory roadmaps that integrate processes, technology, and operating models. Support client interactions with health authorities, including responding to inquiries and managing communications.

Identify opportunities for process standardization, automation, and digital transformation within regulatory operations. Maintain a deep understanding of regulations like ICH E2E, IDMP Modules, and PMS.

Engage with clients to understand their challenges and propose innovative digital solutions in the RA space. Contribute to business development, proposal writing, and thought leadership in regulatory affairs. Build robust internal relationships to deliver integrated solutions.

Possess extensive knowledge of global regulatory frameworks including FDA, EMA, PMDA, ICH guidelines, and GVP Modules.

Demonstrate strong expertise in Good Clinical Practices (GCP) and related compliance frameworks and tools (e.g., Veeva Vault, RimSys). You should be adept at designing and implementing regulatory strategies that align with business objectives and anticipate compliance challenges.

Translate global regulations into clear functional, data, and process requirements. Drive regulatory-driven process and system transformation by partnering with Regulatory, Quality, and IT teams.

Perform impact assessments for regulatory changes and define implementation roadmaps. Enable data governance and ensure submission readiness. Support system configuration and validation activities. Facilitate cross-functional stakeholder alignment.

This role requires 8-12 years of hands-on experience in the regulatory domain, preferably with Veeva Vault RIMS or similar platforms. Proven experience in managing teams and delivering complex regulatory programs is essential, alongside strong interpersonal, written, and presentation skills.