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.

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.

Senior Manager – Regulatory Compliance, SME

Key skills