Shape the future of regulatory excellence at IQVIA

At IQVIA, we work to advance healthcare by helping our clients bring safe, effective medicines to patients. As a Regulatory Affairs Specialist, you will play a key role in ensuring compliance and supporting successful product lifecycle management across Germany, Switzerland, and Austria. You’ll collaborate with leading global pharmaceutical companies and contribute to high‑quality regulatory outcomes that truly make a difference.

What you will do

• Manage country‑level regulatory activities for medicinal products, ensuring full compliance with local requirements.

• Prepare and coordinate regulatory submissions in partnership with internal and external stakeholders, including notifications, renewals, variations, new applications, and MAH transfers.

• Lead submission processes with local Health Authorities and follow up through approval.

• Prepare and translate product labelling into German (e.g., SmPC, PIL) for Germany, Switzerland, and Austria.

• Review and approve artwork and promotional materials in client systems.

• Support regulatory maintenance activities across multiple pharmaceutical products.

• Monitor local pharmaceutical legislation and ensure updates are applied appropriately.

What you need to succeed

• Bachelor’s degree in Life Sciences or equivalent professional background.

• 3 years of experience in EU regulatory affairs for medicinal products, including submission document preparation and coordination.

• Experience within a large regulatory organization, with both centralized and local activities, is an advantage.

• Knowledge of pharmaceutical legislation and regulatory requirements in Germany, Switzerland, and Austria is beneficial.

• Excellent organizational skills, attention to detail, and ability to meet timelines.

• Strong communication skills and a collaborative working style.

• Fluent written and verbal communication skills in German and English.

• Strong computer skills, including MS Office; experience with regulatory information systems and artwork tools is a plus.

Why join IQVIA

When you join IQVIA, you become part of a global team that is dedicated to driving smarter healthcare for everyone, everywhere. You will collaborate with industry experts, grow your regulatory career through continuous learning, and contribute to meaningful work that supports better patient outcomes. We foster a culture of innovation, teamwork, and shared purpose — and we’re excited to welcome passionate professionals like you.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.