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.
About Us The Vifor Pharma Group
- 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
is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.
Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit www.viforpharma.com/career