Regulatory Submissions Specialist

IQVIA Inc; Buenos Aires; On-site; ARS 92,724,000 - 139,086,000; Full time

Job summary

IQVIA Inc is seeking a Regulatory Affairs professional to support clinical trial submissions and marketing authorization activities. You will prepare and review regulatory documents, coordinate with project teams, and ensure adherence to guidelines.

The role involves collaboration with internal and external clients, strong English writing and publishing skills, and the ability to manage multiple projects under supervision. A life sciences background and MS Office proficiency are required.

Qualifications

• Bachelor's degree in Life Sciences or related field completed.
• Master's degree in Life Sciences is a plus.
• 2-3 years of regulatory affairs experience including publishing and submission activities.
• Fluent English in writing, speaking, and reading.
• Strong interpersonal, organizational, and communication skills.
• Solid understanding of R&D processes and applicable guidelines.

Responsibilities

• Prepare and/or review regulatory submissions and documents for trials and marketing authorization.
• Act as a regulatory team member on small projects under guidance.
• Track timelines, coordinate client requests, and manage daily workload with senior staff.
• Participate in project teams with internal and external customers and present materials as needed.
• Support training delivery and process improvements as appropriate.

Skills

Regulatory affairs

Project coordination

English fluency

MS Office

Documentation management

Education

Bachelor's Degree in Life Sciences

Master's Degree in Life Sciences (plus)

Tools

Microsoft Office

Publishing tools

Clinical PDF Publishing

Job description

IQVIA Inc is seeking a Regulatory Affairs professional to support clinical trial submissions and marketing authorization activities. You will prepare and review regulatory documents, coordinate with project teams, and ensure adherence to guidelines.

The role involves collaboration with internal and external clients, strong English writing and publishing skills, and the ability to manage multiple projects under supervision. A life sciences background and MS Office proficiency are required.