Senior Regulatory Submissions Lead

Adelphi Group; New York (NY); Presencial; USD 80.000 - 90.000; Jornada completa

Descripción de la vacante

Omnicom Precision Marketing in New York City seeks a Senior Regulatory Operations Specialist to lead regulatory submissions, manage cross-functional workflows, and maintain regulatory knowledge bases with MLR alignment. You will coordinate with PMs, learn client systems, and ensure timely, compliant submissions for Health/Pharma brands.

The role emphasizes strong writing, organization, and multitasking in a fast-paced agency environment, with in-office expectations and competitive salary

Formación

• 4+ years of experience in a relatable role preferred.
• Familiarity with agency submission process and MLR preferred.
• Strong writing and verbal skills; ability to participate in senior meetings.
• Ability to manage multiple projects as one cohesive program.
• Proficiency with Microsoft Office and regulatory document control systems.

Responsabilidades

• Serve as day-to-day submissions lead and manage workload across team members.
• Ensure submission timelines align with FDA/MLR guidelines and client requirements.
• Collaborate with Project Management to gather materials for timely submissions.
• Navigate client submission systems and organize references and annotations.
• Maintain reference and asset libraries for cross-functional use.
• Execute submissions from kickoff to final Client MLR approval and tracking.
• Provide status updates and support prep of samples when needed.
• Document project trackers and current Client regulatory requirements.

Conocimientos

Interpersonal skills

Problem-solving

Multitasking

Communication skills

Organization

Herramientas

MS Office

Veeva Vault

Zinc

Web-based applications

Descripción del empleo

Omnicom Precision Marketing in New York City seeks a Senior Regulatory Operations Specialist to lead regulatory submissions, manage cross-functional workflows, and maintain regulatory knowledge bases with MLR alignment. You will coordinate with PMs, learn client systems, and ensure timely, compliant submissions for Health/Pharma brands.

The role emphasizes strong writing, organization, and multitasking in a fast-paced agency environment, with in-office expectations and competitive salary