Regulatory Operations Associate

Adelphi Group • New York, NY

5d • Hybrid

About The Position

The Regulatory Operations Associate will manage regulatory submissions for client brands, ensuring accuracy, efficiency, and adherence to industry standards. The role manages day-to-day work for 1–3 client brands, coordinates submissions, maintains tracking and process documentation, and communicates submission status, requirements, and challenges to agency team members. The position collaborates with internal teams and supports compliance with regulatory requirements, including uploading supporting documents and linking tactics to component assets as needed.

The role operates in a fast-paced environment and requires strong planning, organization, communication, time management, and problem-solving skills. To the extent permissible by local law, Omnicom policy requires employees to work in the office at least three days per week, unless additional in-office days are directed by the agency or manager.

Requirements

• Associate's or bachelor's degree preferred.
• At least 1 year of experience in pharmaceutical advertising or a related regulated industry.
• Strong planning, problem-solving, and organizational skills.
• Proficiency in Microsoft Office Suite and Teams.
• Excellent written and verbal communication skills and ability to work effectively in a fast-paced environment.
• Understanding of MLR submission processes, fact checks, and reference annotations, and ability to navigate submission portals.
• Ability to work proactively and independently, with strong time management skills and a team-oriented approach.

Nice To Haves

• Veeva PromoMats Certification.
• Experience with submission portals such as Veeva Vault or Aprimo.

Responsibilities

• Manage day-to-day workload for 1–3 client brands, prioritizing tasks to meet deadlines and staying current on standard operating procedures.
• Communicate with agency team members about submission status, requirements, and challenges.
• Maintain accurate trackers and process decks in accordance with agency administrative processes and ways of working.
• Coordinate submission activities, including uploading documents, tracking status, and downloading MLR comments.
• Collaborate with internal teams and share information and best practices to support seamless submission processes.
• Support compliance with regulatory requirements by uploading relevant supporting documents and linking tactics to component assets as needed.

What This Job Offers

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