Regulatory Submissions Specialist (Veeva RIM)

Syneos Health, Inc.; Argentina; Remote; ARS 600,000 - 900,000; Full time

Job summary

Syneos Health, Inc. in Argentina seeks a Reg Submission Coordinator to manage regulatory submissions end-to-end using Veeva RIM+MSProjects. You will prepare IND, marketing, and lifecycle submissions, ensuring compliance and on-time delivery.

Collaborate with cross-functional teams, maintain submission records, perform quality control, and support client interactions. This role demands meticulous documentation, adherence to timelines, and proactive risk management in a dynamic regulatory

Qualifications

• Experience preparing regulatory submissions to authorities.
• Familiarity with ICH guidelines and regulatory standards.
• Strong documentation and data management skills.

Responsibilities

• Prepares and submits full applications or components of IND, marketing and lifecycle maintenance submissions.
• Performs information processing with high reliability and quality within tight timelines.
• Maintain regulatory databases and records per requirements.
• Conducts quality control reviews of documents and tracks submissions to client.
• Attend client meetings and support project delivery with proactive risk management.

Skills

Regulatory submissions

Veeva RIM+MSProjects

Documentation control

Attention to detail

Cross-functional coordination

Tools

Veeva RIM

MSProjects

Job description

Syneos Health, Inc. in Argentina seeks a Reg Submission Coordinator to manage regulatory submissions end-to-end using Veeva RIM+MSProjects. You will prepare IND, marketing, and lifecycle submissions, ensuring compliance and on-time delivery.

Collaborate with cross-functional teams, maintain submission records, perform quality control, and support client interactions. This role demands meticulous documentation, adherence to timelines, and proactive risk management in a dynamic regulatory