Division: Regulatory Affairs
Company: Vifor Pharma
Seniority Level: Director
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.
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
Vifor Pharma Group is a global pharmaceuticals company. It holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).