Regulatory Operations Manager

Ogilvy Health US • New York, NY

6h

About The Position

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.

Requirements

• 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

Responsibilities

• 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
• 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 This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed