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Regulatory Affairs Specialist(m/w/x)
Coordinating submissions for medicinal products to local Health Authorities for healthcare clients. 3+ years EU experience with medicinal product legislation in DACH region required. Work in a large, data-driven organization focused on healthcare solutions.
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
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- regulatory information systems
- artwork tools
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- IQVIAVollzeitnur vor OrtBerufserfahrenWienab 5.000 / Monat
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Regulatory Affairs Specialist(m/w/x)
Coordinating submissions for medicinal products to local Health Authorities for healthcare clients. 3+ years EU experience with medicinal product legislation in DACH region required. Work in a large, data-driven organization focused on healthcare solutions.
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
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- regulatory information systems
- artwork tools
Über das Unternehmen
IQVIA
Branche
Healthcare
Beschreibung
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
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