FSP – Regulatory & Start-Up Specialist

Job Overview

IQVIA is seeking an FSP – Regulatory & Start-Up Specialist to join their team in Buenos Aires, Argentina. This role is crucial in ensuring regulatory compliance and efficient study start-up processes within the life sciences and healthcare industries, contributing to the acceleration of innovative medical treatments and improved patient outcomes.

Company Overview

IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. Powered by IQVIA Connected Intelligence™, the company delivers actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies, and extensive domain expertise. With approximately 88,000 employees in over 100 countries, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments while protecting individual patient privacy.

Quick Details

• Salary Range: Market Competitive
• Job Type: Full-time
• Qualifications: Bachelor’s Degree
• Experience: 3 Year+

Key Responsibilities

• Lead and manage regulatory document collection, preparation, and submission processes.
• Ensure full compliance with local and international regulatory requirements for clinical trials.
• Facilitate efficient study start-up activities, including site selection and initiation.
• Develop and maintain strong working relationships with regulatory authorities and ethics committees.
• Provide expert guidance on regulatory strategy, risk assessment, and mitigation.
• Support ongoing regulatory maintenance and close-out activities for clinical studies.

Requirements

• Bachelor’s degree in life sciences, law, or a related healthcare field.
• Minimum of 3 years of experience in regulatory affairs or clinical study start-up within the pharmaceutical/CRO industry.
• Strong understanding of global clinical trial regulations and guidelines (e.g., ICH-GCP).
• Excellent communication, organizational, and project management skills.
• Ability to work effectively in a fast-paced, complex, and highly regulated environment.
• Proficiency in English; knowledge of Spanish is highly beneficial.

Benefits

• Opportunity to work with a global leader in clinical research and healthcare intelligence.
• Contribute directly to advancing medical treatments and improving patient outcomes worldwide.
• Access to professional development and extensive career growth opportunities.
• Competitive salary and a comprehensive benefits package.
• Work in a collaborative, innovative, and impactful global team environment.
• Exposure to cutting-edge technologies and advanced data analytics platforms.