Regulatory Operations Specialist

Adelphi Group • New York, NY

9h • Hybrid

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. The role partners with agency brand teams to prepare and upload submission materials into client portals and oversees end-to-end content submissions to ensure they are timely, accurate, and compliant with brand and AMA guidelines. It requires strong planning, problem-solving, organizational, written, and verbal communication skills, as well as the ability to learn new systems and work effectively in a fast-paced, deadline-driven environment.

The specialist collaborates with cross-functional teams to facilitate submissions and address content-related queries. The role also supports workflow improvements, maintains trackers and digital asset management systems, and provides guidance to junior submission specialists. The schedule is 9:00 AM–6:00 PM EST. Omnicom policy requires employees to work in the office at least three days per week, subject to applicable 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.
• Critical-thinking skills and ability to learn new systems and processes.
• Ability to manage submissions accurately and follow client and agency processes.

Responsibilities

• Manage regulatory content submissions for 1–3 client brands, ensuring accuracy, timeliness, and compliance with submission standards.
• Tag and link references cited in promotional materials within client submission systems.
• Collaborate with editors, medical writers, project managers, and other stakeholders to manage timelines, resolve queries, and address reviewer feedback.
• Prioritize workload to meet client deadlines and communicate submission status, requirements, and challenges to agency team members.
• Stay current with standard operating procedures for assigned client brands and communicate process changes to internal teams.
• Maintain trackers and assist with updating client brand process decks.
• Upload clean, correctly named documents, annotated materials, supporting documents, references, and assets to submission portals.
• Open submission placeholders as required and flag missing metadata to the account team where applicable.
• Manage resubmissions, final submissions, validation, functional annotations, and other tasks specified by client regulatory processes.
• Link tactics to relevant component assets and track submitted tactics in the MLR portal.
• Download MLR comments from submission portals and share them with Account Services, Project Management, and Copy.
• Oversee the asset lifecycle in Veeva PromoMats, including organization and version control.
• Track and document digital asset management systems, and troubleshoot and resolve issues.
• Identify process gaps, suggest improvements, and support workflow optimization.
• Ensure submissions are error-free and comply with editorial, regulatory, AMA Style Guide, and brand guidelines.
• Provide guidance and mentorship to junior submission specialists.
• Attend agency team meetings for assigned client brands and participate in product status meetings.

What This Job Offers

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