Regulatory Operations Associate

Adelphi Group • New York, NY

5d • $48,000 - $60,000 • Hybrid

About The Position

The Regulatory Operations Associate manages regulatory submissions for client brands, ensuring accuracy and efficiency while following industry standards. The role manages day-to-day work for 1–3 client brands, prioritizes tasks to meet deadlines, and stays current on standard operating procedures. It coordinates submission activities, maintains trackers and process decks, communicates submission status and challenges, and collaborates with internal teams to support compliant, seamless processes.

Requirements

• At least 1 year of experience in pharmaceutical advertising or a related regulated industry.
• Strong planning, problem-solving, and organizational skills.
• Proficiency with 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

• Associate's or Bachelor's degree preferred.
• Veeva PromoMats Certification.
• Experience with submission portals such as Veeva Vault or Aprimo.

Responsibilities

• Manage the day-to-day workload for 1–3 client brands, prioritizing tasks to meet deadlines and staying up to date on standard operating procedures.
• Communicate submission status, requirements, and challenges to agency team members.
• 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.
• Ensure compliance with regulatory requirements by uploading 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