Regulatory Affairs Director - Zurich

Ort: Switzerland - Glattbrugg/Zurich

Funktion: Regulatory Affairs

Firma: Vifor Pharma

Senioritätslevel: Director

Medha Khanna

Senior Talent Acquisition Manager

+41 58 852 90 82

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Ihr Profil

At Vifor Pharma, we have an excellent opportunity for a Regulatory Affairs Director to lead regulatory affairs activities for our ion-based phosphate binder product. This product is approved in EU, US, Japan and other international markets.

Key responsibilities (but not limited to)

  • Lead the RA activities for the product

  • Be the primary contact at Vifor for major topics related to Health Authority interactions 

  • Coordinate support from relevant internal GRA sub-functions, external consultants and vendors.

  • Manage timelines and resources to achieve stated objectives, ensuring tracking tools and regulatory databases are maintained and up-to-date.

  • Work in close collaboration with Vifor Partner Business functions to integrate all aspects of global regulatory strategy

  • Drive GRA contribution to establish and maximise potential of the product

  • Ensure strategic submissions on plan

  • Develop regulatory strategy to deliver Target Product Profile (TPP) label

  • Provide regulatory input for differentiation versus current and future competition

  • Ensure GRA delivery of LCM related activities

  • Ensure that the interactions between Regulatory and other departments are managed optimally to enable achievement of program targets

  • Foster Vifor reputation with regulators as being science-based, reliable, and trustworthy by advocating for sound regulatory policies

  • Contribute to the development and implementation of processes and procedures relevant to the operations of the regulatory function and its interactions with internal stakeholders.

Requirements

  • MBS, BA in a relevant scientific discipline, or BSN/BSc in Nursing. MA/MS or PhD in life sciences or chemical engineering, or PharmD preferred

  • At least 10 years’ experience in pharmaceutical regulatory affairs

  • Direct experience interacting with national Health Authorities

  • Excellent knowledge of the process for developing and launching products in the EU and internationally, including direct experience with the Centralised Procedure

  • Fundamental understanding of the contents of product dossiers and critical attributes of medicinal products for registration

  • Excellent verbal and written communication skills in English. 

  • Experience in leading a regulatory group or cross-functional team

  • Prior involvement in US registrations or other registrations outside of the EU. 

  • Well known in regulatory community in the EU with good Health Authority contacts. 

  • Understanding and speaking German and/or French is a strong asset


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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