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 newly approved modified release Vitamin D product. The focus of this role is EU.

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 

  • Experience with MRP is a plus

  • 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 Pharmaunternehmen. Sie nimmt in allen ihren Kern-geschäften eine führende Position ein und besteht aus den folgenden Unternehmen: Vifor Pharma und Vifor Fresenius Medical Care Renal Pharma (ein Gemeinschaftsunternehmen mit Fresenius Medical Care). Die Vifor Pharma Gruppe ist an der Schweizer Börse kotiert (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

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