Senior Regulatory Affairs Specialist (m/f/d) Roche Penzberg

• Bertrandt ist ein international tätiger Engineering‑Dienstleister,
• der innovative technische Lösungen für anspruchsvolle
• Industrieprojekte entwickelt. An über 50 Standorten weltweit arbeiten
• rund 12.000 Mitarbeitende eng mit Kunden aus technologiegetriebenen
• Branchen zusammen. Bei Bertrandt agieren Sie in einem professionellen,
• partnerschaftlichen Umfeld und leisten einen wichtigen Beitrag zur

erfolgreichen Umsetzung komplexer Projekte. What to Expect

• Preparation, compilation and maintenance of regulatory documentation
• as well as marketing authorization and registration dossiers for
• complex products in an international context Development and
• implementation of regulatory strategies in accordance with global
• requirements Identification and management of regulatory risks
• Providing advice on regulatory issues and ensuring adherence to
• international compliance and approval requirements Supporting audits,
• including preparing for, conducting, and following up on corrective
• actions Providing technical support and mentoring to team members
• Actively contributing to process optimization, digitalization
• initiatives and the further development of regulatory systems, tools
• and data management Analyzing complex issues and developing and
• implementing sustainable and innovative solutions What you bring: A
• completed bachelor’s or master’s degree in life sciences, data
• science, or a related field; alternatively, a completed apprenticeship
• as a technician, laboratory technician, or a comparable qualification
• Professional experience in Regulatory Affairs, Research & Development
• or Quality Management Initial experience in the field of Healthcare
• Regulatory Affairs Experience in developing and implementing
• improvement and change processes Business-level proficiency in spoken
• and written English Experience from Regulatory Affairs in China would
• be very desirable Firmeninterne Kantine Corporate Benefits Parkplätze
• Unbefristeter Arbeitsvertrag Sehr gute Übernahmechancen Clara Pamela
• Wiegand +49 621 40046324