Regulatory Operations Specialist
About The Position
The Regulatory Operations Specialist manages regulatory submissions and related tasks for 1–3 client brands, following industry standards and agency- and client-established processes. Working with agency brand teams, the Specialist prepares and uploads materials to client submission portals and oversees end-to-end content submissions to ensure they are timely, accurate, and compliant with brand and AMA guidelines. The role requires strong planning, problem-solving, organizational, written, and verbal communication skills, along with the ability to learn new systems and processes and work in a fast-paced, deadline-driven environment. Proficiency in Excel, Word, PowerPoint, Outlook, and Teams is required. The Specialist collaborates with cross-functional teams and supports submission workflows, portal and digital asset management, tracking, validation, resubmissions, and review feedback. The role also involves identifying process improvements, maintaining quality and compliance, and providing guidance to junior submission specialists. The position is scheduled from 9:00 AM to 6:00 PM EST. Omnicom policy requires employees to work in the office at least three days per week, subject to local law and any additional direction from the agency or manager.
Requirements
- Proficiency in Excel, Word, PowerPoint, Outlook, and Teams.
- Excellent planning, problem-solving, organizational, written, and verbal communication skills.
- Ability to work in a fast-paced, deadline-driven environment.
- Ability to think critically and learn new systems and processes.
Responsibilities
- Manage regulatory submissions and day-to-day workload for 1–3 client brands, prioritizing tasks to meet client deadlines.
- Tag and link references cited in promotional materials within client submission systems.
- Collaborate with editors, medical writers, project managers, and other cross-functional teams to manage timelines, resolve queries, and address reviewer feedback.
- Stay current on standard operating procedures for assigned client brands and communicate process changes to internal teams.
- Communicate submission status, requirements, and challenges to appropriate agency team members.
- Maintain updated trackers and help update client brand process decks.
- Attend agency team meetings for assigned client brands and comply with agency administrative processes.
- Upload clean, correctly named documents, annotated pieces, references, assets, and supporting documents to submission portals.
- Open submission placeholders as required and flag missing metadata to the account team where applicable.
- Manage resubmissions, final submissions, validation, and functional annotations according to client regulatory processes.
- Link tactics to relevant component assets and track submitted tactic status in the MLR portal.
- Download MLR comments from submission portals and share them with Account Services, Project Management, and Copy.
- Manage content submissions and ensure accuracy and compliance with submission standards.
- Oversee the asset lifecycle in Veeva PromoMats, including organization and version control.
- Track and maintain digital asset management systems and troubleshoot and resolve issues.
- Identify process gaps, recommend improvements, and support workflow optimization.
- Ensure error-free submissions and compliance with editorial, regulatory, AMA Style Guide, and brand guidelines.
- Provide guidance and mentorship to junior submission specialists.
- Participate in product status meetings and use industry knowledge to improve editorial workflows.
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What This Job Offers
Job Type
Full-time
Education Level
No Education Listed
