Regulatory Affairs Specialist / Manager
I
IQVIA
📍 Frankfurt, Germany, Germany
Job Description
**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....
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....