Stada Arzneimittel AG
61118 Bad Vilbel - Deutschland
Biologe/Biologin
Arbeit
Vollzeit
ab 17.12.2025
Beschreibung
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
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
Quelle: Bundesagentur für Arbeit - Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
Ref-Nr.: 4d1711c291c20bb963d6f3c67ab607ba
Letztes Update:
17.12.2025
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