Regulatory Operations Specialist

Role Responsibilities

• Expertly manage the tagging and linking of references cited in promotional materials within client submission systems.
• Collaborate with editors, medical writers, and project managers to manage timelines, resolve queries, and address reviewer feedback.
• Successfully manage day-to-day workload for 1-3 client brands.
• Stay up to date on the latest standard operating procedures for each assigned client brand.
• Prioritize workload to meet each client's deadline successfully.
• Communicate clearly and effectively with appropriate agency team members about status, requirements, and challenges when working on submissions.
• Maintain updated trackers and assist with updating client brand process decks.
• Communicate changes in processes to the extended internal teams.
• Attend agency team meetings for assigned client brands.
• Comply with agency administrative processes and ways of working.
• Upload clean, properly named documents, and annotated pieces with appropriate references.
• Open placeholders for submissions as required by the client process. Flag missing information (metadata) to the account team, where applicable.
• Responsible for resubmissions, final submissions, validation, functional annotations, etc., as specified by the assigned client brands regulatory process needs.
• Upload relevant supporting documents to accompany submissions.
• Link tactics to relevant component assets as per the assigned client brand's regulatory process.
• Track status of submitted tactics in the MLR portal.
• Download MLR comments from the submission portal and share with Account Services, Project Management, and Copy.
• Upload references and assets to the submission portal for approval.
• Identify process gaps, suggest improvements, and support workflow optimization to enhance submission efficiency.
• Uphold the highest quality standards by ensuring error-free submissions and strict compliance with editorial and regulatory guidelines.
• Provide guidance and mentorship to junior submission specialists to improve process understanding and skill development.
• Stay ahead of industry trends by actively participating in product status meetings and leveraging expertise to improve editorial workflows.

Your Day-to-Day Deliverables

• Manage content submissions, ensuring accuracy and compliance with submission standards.
• Oversee the complete asset lifecycle on Veeva PromoMats, ensuring proper organization and version control.
• Proactively enhance submission workflows and collaborate with internal and external stakeholders.
• Ensure adherence to the AMA Style Guide and brand guidelines in all submissions.
• Track, document, and maintain digital asset management (DAM) systems, troubleshooting and resolving issues efficiently.