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We are looking for a Regulatory Affairs Specialist for our OM Pharma site for a period of 6 months based in Fribourg or in Geneva (depending on your residence). Your role is to coordinate CMC and additional regulatory activities for products under responsibility. Your responsibilities will include, but not be limited to:

• Contribute to overall CMC submission activities including preparation of Quality Modules, review and approval in the frame of life cycle management activities in line with current regulatory guidelines and company strategy
  


• Act as Regulatory contact point with manufacturing plants, quality and R&D functions
  


• Assist in handling the Change Controls: perform the primary evaluation and coordinate the worldwide regulatory assessment, ensure the regulatory implications have been considered
  


• Contribute to compliance check, gap analysis and dossier updates in timely manner
  


• Prepare answers to questions from Health Authorities related to regulatory / CMC topics
  


• Ensure alignment with Global CMC team by liaising with Therapeutic Areas, International, Submission and Regulatory Operations groups to ensure appropriate planning and timely preparation of CMC-related submissions
  


• Handle Regulatory documentation for the products under responsibility
  


• Perform preparation and filing of variations, renewals and application dossiers to Swissmedic or other heath authorities

We are looking for a customer- and service-oriented person who brings experience in working with stakeholders across diverse teams both internally and with external partner companies. Furthermore, your profile meets the following criteria:

• Degree in Life Science in a relevant discipline (pharmacy, chemistry, biochemistry, biology)
  


• 1 to 3 years experience in Regulatory Affairs, experience in regulatory CMC writing will be an advantage, especially within the Biologics area
  


• Good knowledge and appropriate interpretation of of European regulation, guidelines, directives (experience with Swissmedic highly


• appreciated)
  Good knowldege of standard IT tools, eCTD experience
  


• Fluent in English and French (good command of both, written and spoken language is mandatory), good command of German would be an advantage

You describe yourself as a solution oriented and flexible person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines. Thanks to you strong communication and negotiation skills, you are able to lead projects successfully and to interact with senior stakeholders from different departments.

Über uns

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist. Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen. Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Für mehr Informationen gehen Sie bitte auf: www.viforpharma.com/de/ueber-vifor-pharma/wer-wir-sind

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