Careers

Vifor Pharma has an exciting opportunity for a Senior Manager Regulatory Affairs to join our Global Regulatory Affairs (GRA) function based at our global headquarters in Glattbrugg, Switzerland.

Reporting to the Head of Regulatory Affairs Iron deficiency portfolio, the incumbent will be responsible for effective management and leadership of the Regulatory Affairs components related to the iron deficiency portfolio including our blockbuster iron deficiency product.

Key responsibilities include (but not limited to):

• Lead the iron deficiency portfolio regulatory affairs activities

• Be a contact for Vifor Pharma for major topics related to Health Authority interactions for the iron deficiency portfolio

• Lead GRA processes for relevant projects with timely strategic input in support of coordinated registration activities in EU, US, CH, AU, CN & JP

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

• Work in close collaboration with the RA International Strategy function to integrate all aspects of global regulatory strategy

• Drive GRA contribution to establish and maximise potential of the iron deficiency portfolio

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

• Provide regulatory input for differentiation versus current and future competition

• Ensure GRA delivery of lifecycle management related activities

• Monitor, analyze, and anticipate changes in the regulatory environment, including their impact to the iron deficiency portfolio, submission targets or clinical trial designs; implement necessary adjustments to strategies or content

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

• Act as deputy to Head of RA Iron Deficiency

Requirements:

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

• At least 10 years’ experience in Pharmaceutical Industry and at least 5 years experience in Regulatory Affairs (Strategy)

• Direct experience interacting with national Health Authorities

• Experience with EU centralised procedures and MRP

• Excellent knowledge of the process for developing and launching products in the EU and internationally

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

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

• Prior involvement in US registrations or other registrations outside of the EU is a plus

• Excellent communication skills and fluency in English

• Strong track record of building effective working relationships and successfully influencing at all levels across the organization to achieve business goals

• Experience of working in a cross functional environment

If this opportunity is of interest to you, please apply by submitting your updated CV and a cover letter via our careers portal.