Regulatory Affairs Director - Zurich

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Regulatory Affairs

Compagnie: Vifor Pharma

Niveau de Séniorité: Director

Medha Khanna

Senior Talent Acquisition Manager

+41 58 852 90 82

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Votre 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


A propos de nous

Le Groupe Vifor Pharma est une entreprise pharmaceutique internationale. Il occupe une position de leader dans toutes ses activités clés et se compose des entreprises suivantes: Vifor Pharma et Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care). Le Groupe Vifor Pharma est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348.

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Conditions pour les agences de placement