Division: Regulatory Affairs
Company: Vifor Pharma
Seniority Level: Senior Manager
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
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.
At Vifor Pharma, we use our skills, dedication, and entrepreneurial spirit to offer innovative solutions in iron deficiency, nephrology and cardio-renal therapies, so we can help patients around the world live better, healthier lives. This is why we come to work every day.
Are you empowered to create a better world, and be part of life changing work? As a global pharmaceutical company, we offer the chance to be part of a worldwide team, where passion and commitment are met with opportunities for professional and personal development. Learn more at viforpharma.com/career.
As we work to support patients, we also take care for our employees’ professional and personal growth and well-being. We show appreciation and recognition through attractive benefits that will enhance your life, develop you, empower you to grow, and create your own career journey with us.
If you find that the role above is not suitable for your experience or career goals, but you want to keep in touch and learn more about Vifor Pharma and future career opportunities, join our Vifor Pharma Talent Community.