Job Detail

Ihr Profil

We are currently looking for an  Regulatory Affairs Specialist International  to join our team. Based in Meyrin/Geneva, you report to the Regulatory affairs International Team Lead and your responsibilities include the following tasks:

• Manage successful submissions for new marketing authorisations, renewals, variations and line extensions for International regions (LATAM, MEA, APAC, CIS) and drive the approval process


• Coordinate responses to Q&A for projects under responsibility and ensure they are handled in a timely manner 


• Responsibility for the designated regulatory projects with respective deadlines and forecasted budget, from regulatory assessment to implementation


• Collaboration with the EU/CH/US and Regulatory Excellence groups to ensure appropriate planning and timely execution of the regulatory activities


• Ensure compliance of dossiers with legislation and with the general requirements in respective regions


• Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to the Health Authorities


• Ensure tracking tools and regulatory databases are maintained up to date according to internal guidelines

For this role, we are looking for a customer and service-oriented person who brings experience in working with a wide variety of stakeholders across diverse teams both internally and with external partner companies bringing the following profile :

• University degree in Scientific area




• At least 2 years of work experience in Regulatory Affairs in the International markets (LATAM, MEA, APAC, CIS) in the pharmaceutical industry




• Excellent communication and negotiation skills 




• Fluent in English and French both in oral and written conversation

You can navigate organizational complexity through teamwork, clearly structured data enquiries and effective communication. You are 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.

Über uns

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

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