The Regulatory Operations Specialist’s main responsibility is to manage regulatory submissions and associated tasks for 1-3 client brands while following industry standards, as well as agency-and client-established processes. The Specialist will partner with agency brand teams to help prepare and upload submission materials into client submission portals. This role requires excellent planning, problem-solving, organizational, written, and verbal communication skills to ensure accuracy and efficiency of submissions, as well as the ability to work in a fast-paced, deadline-driven environment. The Specialist must be a critical thinker and be able to learn new systems and processes for the agency and their assigned client brands. Proficiency in Excel, Word, PowerPoint, Outlook, and Teams required.
Responsibilities:
- Successfully manages day-to-day workload for 1-3 client brands.
- Stays up-to‑date on the latest standard operating procedures for each assigned client brand.
- Prioritizes workload to successfully meet each client's deadline.
- Communicates clearly and effectively with appropriate agency team members about status, requirements, and challenges when working on submissions.
- Maintains updated trackers and assist on updating client brand process decks.
- Communicates changes in processes to the extended internal teams.
- Attends agency team meetings for assigned client brands.
- Complies with agency administrative processes and ways of working.
- Uploads clean, properly named documents, and annotated pieces with appropriate references.
- Opens placeholders for submissions as required by client process. Flag missing information (metadata) to the account team where applicable.
- Responsible for resubmissions, final submissions, validation, and functional annotations, as specified by assigned client brands’ regulatory process needs.
- Uploads relevant supporting documents to accompany submissions.
- Links tactics to relevant component assets as per assigned cli