Regulatory Submissions Lead — 1–3 Brands (Veeva)

Interpublic; United States; On-site; USD 48,000 - 60,000; Full time

Job summary

Omnicom Health is seeking a Regulatory Operations Specialist to manage regulatory submissions for 1-3 client brands, ensuring accuracy and compliance with AMA guidelines. You will partner with agency brand teams to prepare materials for client submission portals and maintain high quality in a fast-paced environment.

The role requires proficiency in Excel, Word, PowerPoint, Outlook, and TEAMS, strong planning and communication, and the ability to mentor junior staff while improving submission

Qualifications

• Experience managing regulatory submissions for client brands.
• Ability to collaborate with editors, writers, and project managers.
• Strong planning and organizational skills to meet deadlines.
• Proficiency with client submission portals and AMA guidelines.

Responsibilities

• Expertly manage tagging and linking of references cited in promotional materials.
• Collaborate with editors, medical writers, and project managers to manage timelines.
• Successfully manage day-to-day workload for 1-3 client brands.
• Stay up to date on SOPs for each assigned client brand.
• Prioritize workload to meet client deadlines.
• Communicate status and requirements clearly to teams.
• Maintain trackers and assist with updating brand process decks.
• Ensure submissions comply with AMA guidelines.
• Provide guidance to junior submission specialists.

Skills

Regulatory submissions

Project coordination

Attention to detail

Written & verbal communication

Tools

Excel

Word

PowerPoint

Outlook

TEAMS

Job description

Omnicom Health is seeking a Regulatory Operations Specialist to manage regulatory submissions for 1-3 client brands, ensuring accuracy and compliance with AMA guidelines. You will partner with agency brand teams to prepare materials for client submission portals and maintain high quality in a fast-paced environment.

The role requires proficiency in Excel, Word, PowerPoint, Outlook, and TEAMS, strong planning and communication, and the ability to mentor junior staff while improving submission