RA Infrastructure Submission Publishing Specialist 100% - St Gall

Lieu: Switzerland - St Gallen

Fonction: Regulatory Affairs

Niveau de Séniorité: Specialist

Votre profil

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 

A propos de nous

Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.

Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Pour de plus amples informations, veuillez consulter www.viforpharma.com/career

Afficher/masquer le contenu

Xing Send to a friend

Conditions pour les agences de placement