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STADA Arzneimittel GmbH
What you can expect

• You are responsible for the lifecycle management and maintenance of an entire biosimilar project
• You handle post-approval changes and submissions (lifecycle management) and prepare administrative documents such as cover letters, tracking tables, and application forms
• You process dossier documents using document management software and generate eCTD sequences with publishing software
• You initiate change control processes for variations and maintain entries in the regulatory information management system (RIMS), including tracking procedures and xEVMPD submissions
• You organise project trackers for marketing authorisation and variation procedures, and keep external partners and affiliates informed about the status of regulatory procedures
• You compare dossiers between EU and non-EU countries and maintain product information (PI) in 25 EU languages
• You update product information in accordance with reference product text and QRD requirements, and coordinate the translation of PI texts for authorisation and variation procedures
• You request certificates and prepare statements for external partners
• You review artworks and ensure their compliance with EMA-approved mock-ups and EC guidelines
• You contribute to continuous improvement initiatives within the department and jointly lead the revision of existing internal processes to develop optimisation proposals

Who we are looking for

• You hold a Degree in life sciences (master in pharmacy, chemistry, biology, biotechnology or related discipline), a PhD or MBA is a plus
• You have a professional experience in Global Regulatory Affairs for Biologics and/or Small Molecules (clinical, registration or lifecycle)
• You are experienced with FDA and Regulatory Affairs in other non-EU countries
• You are expereinced with medical devices and the EU Regulation
• You have excellent knowledge of English is required, German and additional language is a plus
• The position is to be filled until 30 September 2027