Careers

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