Ihr Aufgabengebiet
- Keep in touch with distributors and consultants, collaborate with local partners and health authorities
- Implement the regulatory strategies by determining submission and approval requirements in targeted regions
- Supervise regulatory submissions, and oversee all aspects that are important to gain marketing authorization in line with country-specific regulations
- Confluence within cross-functional project teams and guidance on submission processes, performing as a primary Regulatory Affairs interface
- Compliant with applicable domestic and international regulatory laws/standards, act within different processes, and SOPs, create and develop these
- Coordination, preparation, and documentation of Scientific Advice meetings, convey and establishment of high-quality dossiers, monitor changes and updates to applicable legislations
Ihr Hintergrund
- Degree in pharmacy or life science (Master or PhD preferred)
- Long-term experience in regulatory affairs (pharmaceutical development), at least minimum 10 yers
- Background in biosimilar, cell and gene therapy development, health authority interactions
- Experienced in dossier compilation, excellent self-organization skills, team-oriented
- Superb knowledge of applicable regulatory framework
- Very good knowledge of MS Office applications
- Structured, ability to manage multiple parallel tasks, goal-oriented
- Excellent communication skills in German and English (both written and spoken)
Ihre Benefits
- Spannende Herausforderungen in einem zukunftstr chtigen und wachsenden Unternehmen
- Eine offene Arbeitsatmosph re in einer offenen Unternehmenskultur mit kurzen Kommunikationswegen
- Ein attraktives Verg tungspaket sowie interessante Weiterentwicklungsm glichkeiten
Gender-Hinweis
Aus Gr nden der besseren Lesbarkeit wird auf die gleichzeitige Verwendung der Sprachformen m nnlich, weiblich und divers (m/w/d) verzichtet. S mtliche Personenbezeichnungen gelten gleicherma en f r alle Geschlechter.