Regulatory Operations Manager

About the Role

We are seeking a highly motivated and experienced Regulatory Operations Manager to lead our submissions team and oversee the Medical Legal Review (MLR) process across multiple clients and brands within Ogilvy Health. This role serves as the central submissions expert—responsible for ensuring submission excellence, maintaining compliance, and driving consistency across all touchpoints.

The Regulatory Operations Manager will participate directly in submissions while also managing and guiding team members, collaborating cross‑functionally with Account and Project Management, and serving as a strategic partner to client-side submissions and regulatory contacts.

What You’ll Do

Submission Management

• Ensure successful execution of all MLR submissions across assigned brands, from intake to approval
• Maintain expert level knowledge of each brand’s submission requirements and ensure documentation is up to date
• Collaborate with account, project management and editorial teams to ensure submission materials are complete, accurate, and appropriately annotated
• Oversee and participate in tagging and linking of claims and references in Veeva Vault, ensuring accuracy and alignment with regulatory requirements
• Facilitate pre-review quality control checks and ensure all feedback from MLR is captured and addressed appropriately

Operational Excellence

• Track and manage submission timelines and deliverables using internal and client systems (e.g. Veeva, Smartsheet)
• Maintain detailed records of submission activity and support preparation of metrics, reports, and audits
• Support ongoing training and upskilling of internal teams on submission best practices and system navigation

What You’ll Need

• 4-5 years of advertising agency experience handling MLR submissions
• Project and process management skills, with demonstrated ability to meet deadlines and prioritize tasks
• Strong communication and interpersonal skills; able to serve as a liaison between internal teams and external client partners
• Excellent attention to detail and organizational and problem-solving abilities
• Ability to work independently while managing multiple brands or therapeutic areas simultaneously
• Proficiency in Microsoft Office Suite, Adobe Acrobat and submission tracking platforms

How We’ll Support You 

Ogilvy celebrates its people. Fully. Enthusiastically. Unhesitatingly. We’ll empower you with the tools you’ll need to succeed. We’ll give you the autonomy to seek out new paths and better ways of doing things. We’ll support you with colleagues who are experts in their disciplines, drawn from across the Ogilvy network. And we’ll provide opportunities for you to do work of which you’ll be proud, with people you’ll be proud to call your teammates. 

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