We are looking for an experienced RA Infrastructure Submission Publishing Specialist for our production site in St Gallen. At this position, you work within the Regulatory Affairs department and are responsible for the Quality of planning and the information and inputs provided to the stakeholders and projects. You show Vifor’s ability to meet changing technical requirements in the area of Regulatory Infrastructure.
Your main tasks are :
● Collection of documents for submissions, ensuring e compliance, formatting, compilation, publishing and dispatch of electronic and paper submissions to meet health authority requirements
● Interact with internal departments to ensure timely submissions and to support global filings
● Work to achieve business objectives and priorities within RA Infrastructure; specific focus on electronic document management, electronic submissions, submission tracking and other electronic systems used by GRA
● Maintenance, coordination of updates and problem solving issues related to publishing software
● Organisation of access to electronic gateways to enable submissions being uploaded to Health Authorities
● Work closely within a team in a globally focused environment to achieve team and company goals
● Manage the regulatory documentation in accordance with regulations, in-housenSOPs, workflows and systems.
● Further tasks according to directives from Line Manager.
Your main responsibilities are:
● Planning, coordination, publishing, archiving and ensuring high quality, “Right First Time” dossiers
● Maintenance of internal technologies and processes to be in line with the company business objectives, standard procedures and policies, regulatory authority requirements and partner company agreements
● Work closely with GRA, internal stakeholders and IT to define requirements, evaluate technologies, implement operational solutions for new systems and interfaces and related processes to meet the evolving business and regulatory environment
● Support system upgrades/updates to ensure health authority requirements and compliance standards are met
● Review and analyse internal technologies and processes, identify inconsistencies and support activities to be in line with the company business objectives, standard procedures and policies, regulatory authority requirements and partner company agreements
Your profile:
● Minimum of 2-3 years’ experience in the pharmaceutical industry in a relevant area
● Knowledge of Regulatory Affairs submission process in particular in eCTD publishing, eDMS and Regulatory Information Management tools
● Excellent Microsoft Office and Adobe Acrobat skills
● Experience of planning and compiling submissions for CH, EU, US and ROW
● Fluent in English. Knowledge of German is an asset.
● Publisher with experience of using docuBridge
● Experience of using PDF tools such as DXC toolbox
●Familiarity with document requirements of ICH/GCP and other regulatory guidance’s appropriate for the preparation
Die Vifor Pharma Gruppe ist ein globales Spezialitäten-Pharmaunternehmen. Sie hat sich zum Ziel gesetzt, globale Marktführerin in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu werden. Das Unternehmen ist der bevorzugte Partner für Pharmaprodukte und innovative, patientenorientierte Lösungen. Die Vifor Pharma Gruppe will Patienten mit schweren und chronischen Krankheiten auf der ganzen Welt dabei helfen, ein Leben in besserer Gesundheit zu führen. Das Unternehmen entwickelt, produziert und vermarktet pharmazeutische Produkte für eine optimale Patientenversorgung. Die Vifor Pharma Gruppe nimmt in allen ihren Kerngeschäften eine führende Position ein und besteht aus folgenden Unternehmen: Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma (ein gemeinsam mit Fresenius Medical Care geführtes Unternehmen); und OM Pharma.
Die Vifor Pharma Gruppe hat ihren Hauptsitz in der Schweiz und ist an der Schweizer Börse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348) kotiert.
Weitere Informationen finden Sie auf www.viforpharma.com/career
Inhalt ein-/ausblenden