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Senior Manager – Regulatory Compliance, SME
EYSenior Manager – Regulatory Compliance leading IT implementation projects in regulated environments. Responsible for guiding regulatory strategy and engaging with clients to deliver compliant solutions while ensuring operational efficiency.
Tech Stack
Tools & technologiesPMPVault
About the role
Key responsibilities & impact- 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
- 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.
- Stay current with changing regulatory requirements, assess impacts, and advise proactive client strategies.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategy developmentregulatory submissionsdossier preparationlifecycle managementRIMS implementationdata integrityprocess standardizationautomationdigital enablementIDMP compliance
Soft Skills
interpersonal skillswritten communicationpresentation skillsteam managementsolution designingclient engagementthought leadershipproactive strategy advisingrelationship buildingprocess optimization
Certifications
Regulatory Affairs Certification (RAC)Project Management Professional (PMP)