Senior Regulatory Affairs Manager Biosimilars (gn)

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.