Senior Regulatory Operations Specialist

The Senior Regulatory Operations Specialist’s main responsibility is to oversee regulatory submissions and associated tasks for a portfolio of brands, following industry standards, as well as agency and client-established processes. The Specialist will partner with agency brand teams and junior specialists to 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 learn new systems and processes for the agency and their assigned brand portfolios. Proficiency in Excel, Word, PowerPoint, Outlook, and Teams required. Working knowledge of other industry-standard platforms, such as Workfront and Egnyte, a plus.

• Collaborates with internal brand teams (account, copy, integrated production/project management) to prepare and submit completed digital and print projects for medical/legal/regulatory (MLR) submissions.
• Enforces organizational policies, standards, and procedures to comply with applicable regulations, and submission procedures at agency.
• Manages specific brand operational needs including tactic maintenance, destruction, and archival.
• Assists in training junior staff members, as needed.
• Enforces industry standards for all MLR submissions per FDA/OPDP regulations, as well as adhere to agency and
• Maintains a system that tracks and records all submission files and final materials.
• Maintains internal client brand submissions playbooks.
• Creates and maintains process decks outlining the client's preferred submission method.
• Represents Reg Ops in client-facing meetings.
• Owns brands across multiple books-of-business.
• Juggles a heavy workload with client-driven deadlines.
• Acts as the subject matter expert on standard operating procedures for each assigned client brand.
• Works with management to shape internal best practices and ways of working.
• 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 trackers and updates brand process decks.
• Communicates changes in processes to the extended internal teams.
• Attends agency team status meetings for assigned client brands.
• Complies with agency administrative processes and ways of working.
• Uploads clean, properly named documents, and annotates pieces with appropriate references.
• Opens placeholders for submissions as required by client process. Flags missing information (metadata) to the account team where applicable.
• Responsible for resubmissions, final submissions, validation, 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 client brands’ regulatory process.
• Tracks status of submitted tactics in the MLR portal.
• Downloads MLR comments from submission portal and shares with account, project management, and copy.
• Uploads references and assets to the submission portal for approval.

• Experience:
  
  3+ Years Pharmaceutical advertising agency or another regulated industry.

• Deep understanding of the MLR process and advanced knowledge of the annotating/referencing process.
• Working knowledge of submission structures and client submission portals, including Veeva Vault and
• Expert troubleshooting and finding Veeva workarounds.
• Strong planning, problem-solving, prioritization, and organizational/time management skills.
• Proficient with Microsoft Office Suite including Teams.
• Working knowledge of other industry-standard platforms, such as Workfront and Egnyte, a plus.
• Excellent written and oral communication skills.

• Must know how to juggle multiple brands and a heavy workload while meeting client's deadlines.
• Must be an active contributor to the agency internal brand team and Reg Ops team process improvements and…