Beschreibung

As a Regulatory Affairs Specialist, you will ensure compliance and support product lifecycle management across Germany, Switzerland, and Austria, collaborating with pharmaceutical companies to achieve high-quality regulatory outcomes.

Anforderungen

• •Bachelor’s degree in Life Sciences or equivalent professional background
• •3+ years of experience in EU regulatory affairs for medicinal products
• •Experience within a large regulatory organization
• •Knowledge of pharmaceutical legislation and regulatory requirements in Germany, Switzerland, and Austria
• •Excellent organizational skills and attention to detail
• •Strong communication skills and 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

Aufgaben

• •Manage regulatory activities for medicinal products
• •Ensure compliance with local requirements
• •Prepare and coordinate regulatory submissions
• •Collaborate with stakeholders on notifications, renewals, variations, and new applications
• •Lead submission processes with local Health Authorities
• •Follow up on submissions until approval
• •Prepare and translate product labeling into German
• •Review and approve artwork and promotional materials
• •Support regulatory maintenance for multiple pharmaceutical products
• •Monitor local pharmaceutical legislation and apply updates

Tools & Technologien