Job Detail

Ihr Profil

We are currently looking for a Regulatory Affairs Partner Business Manager to join our Regulatory Affairs team. This role reports directly to the Head Regulatory Affairs Business Partner and is planned to be based in Zurich. Your responsibilities will include:

• Acts as Single Point of Contact between Regulatory Affairs of the partner company, local regulatory representatives of Vifor Pharma and corporate or regional stakeholders


• Manages successfully assigned regulatory projects


• Maintains the assigned Regulatory Data Base Entries in TrackWise according to internal guidelines


• Organizes and supports Regional Regulatory Meetings with the partner companies


• Has oversight on all regulatory actions in the area of responsibility


• Clarifies requirements for planned regulatory activities


• Represents GRA International at in-house meetings, e.g. Demand Review Meeting


• Manages the response to Health Authority questions / requests for information


• Systematically identify and eliminate insufficiencies/discrepancies in the approved regulatory documentation


• Support GMP inspections of manufacturing sites by competent authorities 


• Supplies Regional Hub / partner companies with required regulatory documents


• Improves internal regulatory work flows and processes


• Ensures compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Global Regulatory Affairs such as the Therapeutic Groups, Labelling, RegOps and CMC


• Keeps up to date with the latest regulatory requirements with the focus on the key market Japan.


• Further tasks according to directives from Line Manager

The successful candidate is willing to work effectively with a wide variety of personnel across diverse teams and functions internally as well as external partners. In addition, you will bring the following profile:

• Degree in Life Sciences


• 4 to 6 years of experience in Regulatory Affairs, preferably in Japan or in any other APAC country


• Good command of English and Japanese


• Leadership and cross-cultural competences


• Strategic thinking, analytical and result-oriented mindset


• Ability to analyze the regulatory requirements, perform comprehensive gap assessments and build effective regulatory strategies


• Project and matrix team management capabilities (direct/indirect people management experience is an advantage)


• Computer literacy: advanced skills in Word, Excel and PowerPoint


• This position demands excellent communication and negotiation skills at all levels, and discretion in the handling of confidential information

You describe yourself as a good communicator, with strong teamwork skills as well as good organization and negotiation abilities. You demonstrate accuracy and attention to details with a focus on quality and regulatory requirements. Finally, you are able to cope with stress and demonstrate discretion in the handling of confidential information

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

Inhalt ein-/ausblenden