Your tasks

• Supporting the admissions department in the creation, preparation and merging of digital admission documents
• Participation in national and international approval processes from application preparation to market approval
• Coordination and administrative support of worldwide approval procedures
• Creation, updating and management of regulatory dossiers
• Preparation of product information and digital application forms for European and US approval procedures
• Support in processing registration renewals, extensions and changes, including the compilation of required documentation.
• proper filing of regulatory documents
• Application of applicable regulatory and legal requirements in the field of Electronic Regulatory Affairs
• internal and external interface function

Your profile

• Completed commercial training, e.g., as a pharmaceutical technical assistant (PTA) (m/f/d) or pharmaceutical commercial employee (PKA) (m/f/d), or a comparable qualification.
• practical experience in a pharmaceutical company with knowledge of the specific processes, requirements and framework of the industry
• Ideally, at least 5 years of relevant experience in a comparable role within the pharmaceutical industry.
• Experience in Regulatory Affairs, preferably in an assistant position, is advantageous.
• Safe handling of MS Office applications
• Experience with regulatory database systems, preferably eCTD systems
• good English skills
• Strong communication skills and team orientation
• structured and organized way of working
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