Agile-Rc-Regulatory Compliance-Regulatory - SME-Senior Manager

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Senior Manager – Regulatory Affairs

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We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world.

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Manager actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The opportunity

We are seeking an experienced Manager with deep expertise in Regulatory Affairs to lead regulatory strategy and IT-enabled transformation initiatives in regulated GxP environments. This role requires strong consulting skills, industry knowledge, and the ability to translate regulatory strategy into scalable, compliant solutions for global clients.

Role Overview

As a Senior Manager – Regulatory Compliance, you will lead IT implementation projects in regulated GxP environments, leveraging your deep expertise in Regulatory Affairs and Regulatory Information Management Systems (RIMS) and strong consulting capabilities.

Your primary responsibility will be to partner with clients to understand their business needs and translate strategic objectives into innovative, practical solutions. You will play a pivotal role in establishing and nurturing relationships across internal teams and external stakeholders, ensuring alignment with our commitment to quality and compliance.

This is a leadership role that demands strategic thinking, relationship-building, and a passion for delivering excellence in a highly regulated environment.

Your key responsibilities

Client Responsibilities

• Lead global regulatory strategy development, ensuring compliance with FDA, EMA, MHRA, PMDA, and other health authorities
• Provide expert guidance on regulatory submissions, dossier preparation, and lifecycle management across multiple markets
• Drive RIMS implementation and optimization (e.g., Veeva Vault RIM) to improve data integrity and regulatory efficiency
• Design regulatory roadmaps aligning processes, technology, and operating models
• Support health authority interactions, responses to queries, and regulatory communications
• Identify opportunities for process standardization, automation, and digital enablement within regulatory operations
• Deep understanding of regulations and guidelines, including ICH E2E, FDA, EMA, IDMP Modules, PMS and other international standards
• Support clients in interactions with health authorities, including responding to queries and managing regulatory communications.
• Participate in business development activities, including proposals, client presentations, and thought leadership in regulatory affairs.
• Ensure technology strategy alignment, including Regulatory systems and safety database systems and automation solutions.
• Build strong internal relationships within Risk Consulting and across service lines to deliver integrated solutions.
• Engage with client stakeholders, understand their challenges, and propose innovative digital solutions in the RA space that enhance compliance and efficiency.
• Contribute to business development, proposals, client presentations, and regulatory thought leadership
• Stay current with changing regulatory requirements, assess impacts, and advise proactive client strategies

People Responsibilities

• Develop people through effective coaching and mentoring
• Conduct performance reviews and contribute to performance feedback
• Contribute to people-related initiatives including recruiting, retaining, appraisal and training
• Contribute towards building and strengthening team competency for Regulatory Compliance and Risk consulting
• Participate in the organization-wide people initiatives
• Maintain an educational program to develop skills of team members continually

Decision-Making Responsibilities:

• Support management in workforce planning, resourcing strategy, go to market strategy and demand generation
• Understand the business requirements clearly and lead practice development initiatives as required
• Developing and implementing strategic plans to help clients navigate complex regulatory environments.
• Overseeing project teams and ensuring that regulatory submissions and other deliverables are completed on time and within budget.
• Building and maintaining relationships with key stakeholders, including regulatory agencies, clients, and industry groups.
• Bring out of the box thinking mindset, and analytical thinking capability to enhance service delivery
• Always maintain connections with clients to tap opportunities for constant growth and improvement
• Lead business growth, pursuits and client proposals for Enterprise Risk/Regulatory Compliance, directly working with the regional partners Directors and Senior Managers.

Other Responsibilities

• Oversee regulatory operations / global regulatory transformation programs, ensuring compliance with regulatory requirements and delivery within timelines and budgets
• Monitor global regulatory changes and assess their impact on client strategies and compliance obligations.
• Represent clients during audits, inspections, and meetings with regulatory authorities.
• Lead RIMS implementation projects, ensuring seamless integration with other enterprise systems and compliance with data standards (e.g., IDMP, xEVMPD).
• Mentor and develop regulatory teams, fostering a culture of compliance, innovation, and continuous improvement.
• Collaborate with cross-functional teams, including clinical, quality assurance, and supply chain, to ensure integrated regulatory strategies.
• Drive adoption of advanced technologies such as AI/ML for regulatory intelligence and predictive analytics.

Skills and attributes for success

• Extensive knowledge of global regulatory frameworks, including FDA, EMA, PMDA, ICH guidelines, GVP Modules, and regional requirements.
• Strong expertise in Good Clinical Practices (GCP), and related compliance frameworks and related tools (e.g., Veeva Vault, RimSys, Aris, Lorenz).
• Ability to design and implement regulatory strategies that align with business objectives and anticipate compliance challenges.
• Translate regulatory requirements into business and system needs Interpret global regulations (e.g., FDA, EMA, ICH, MDR) and convert them into clear functional, data, and process requirements.
• Drive regulatory-driven process and system transformation Partner with Regulatory, Quality, and IT teams to design and implement compliant processes and digital solutions (RIM, submissions, labeling systems).
• Perform impact assessments for regulatory changes Assess impact of new/updated regulations on existing processes, systems, and data; define implementation roadmap and compliance strategy.
• Enable data governance and submission readiness Ensure structured, traceable, and compliant regulatory data across submissions, registrations, and lifecycle management.
• Support system configuration and validation activities. Collaborate with IT and validation teams to ensure regulatory requirements are accurately configured, tested, and documented (aligned to GxP expectations). Facilitate cross-functional stakeholder alignment Act as a bridge between Regulatory Affairs, Quality, IT, and business users to ensure consistent understanding and execution of compliance requirements.
• Excellent communication skills for conveying complex regulatory information to stakeholders.
• Strong analytical and problem-solving skills for evaluating regulatory trends and operational risks.
• Precision and attention to detail in preparing regulatory documentation and ensuring compliance.
• Familiarity with electronic submission standards (eCTD, NeeS) and data standards (IDMP, xEVMPD).
• Ability to work collaboratively with cross-functional teams across clinical, regulatory, and quality domains.
• Commitment to high ethical standards and adherence to all applicable laws and regulations.

To qualify for the role, you must have

• 8–12 years of hands-on experience in regulatory area with preferable experience on Veeva Vault RIMS or similar platforms.
• Proven experience in regulatory affairs and RIMS implementation or management.
• Strong interpersonal, written, and presentation skills.
• Experience managing teams and delivering complex regulatory programs
• At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations
• Experience in managing team and solution designing

Ideally, you’ll also have

• Certifications such as Regulatory Affairs Certification (RAC) or Project Management Professional (PMP)
• Experience with global regulatory submissions and lifecycle management, global audits and inspections.
• Familiarity with emerging technologies in regulatory affairs, including AI/ML and automation tools.
• Knowledge of IDMP compliance and structured data management for regulatory processes.
• Experience in industry leading tools – Veeva vault, RimSys, Lorenz, etc.

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way that’s right for you