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Regulatory affairs manager
Amaris is an independent and international Consulting Group specialized in Management and Technologies.
Amaris operates in over 45 countries delivering services in Business & Management Consulting, IT/Information Systems, Telecommunications & Networking, Engineering, Pharmaceutical & Biotechnology.
Since 2007, the company has grown exponentially and is committed to building lasting relationships with its clients, delivering innovative solutions from project inception to execution.
- Prepare and update technical regulatory documents according to documentation standards - Planning and launching projects (e.g. submission preparation); - Creation, review and approval of regulatory requirements and technical files; - Assessment and approvals of change requests; - Maintains regulatory documents in document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint). - Define and maintain an overview of the regulatory requirements and changes; - Release of communication material (IFU, leaflets, brochures); - Collaborate with regulatory product managers
- Scientific background based on education as labor specialist (CTA, PTA) or BA / BS (or equivalent) in chemistry, biology or pharmacy. - At least 2 years experience in regulatory affairs in a pharmaceutical or medical devices industry - Profound knowledge of document management and ability to develop technical files/design dossiers - Fluent in English (Written and spoken), German is an advantage - Good communication skills - Autonomous