Location: Switzerland - Glattbrugg/Zurich
Function: Regulatory Affairs
Company: Vifor Pharma
We are currently hiring a Head of Regulatory Affairs (one Therapeutic Area) in our global RA team. In this role you will be the deputy to the Head Global Regulatory Affairs for specific projects; and therefore a key leader in our growing team as we aim to further build and strengthen Vifor Pharma’s reputation as a star amongst Swiss specialty pharmaceutical companies.
You will be responsible for the following tasks:
- Manage a Therapeutic RA team on designated regulatory projects in compliance within respective project plans and timelines
- Lead GRA processes for assigned projects with timely strategic input in support of coordinated registration activities in EU, US, CH, AU, CN & JP
- Review and approve global regulatory strategies & submissions, as well as company contributions to policy consultation or legal proceedings
- Monitor, analyze, and anticipate changes in the regulatory environment, implement necessary adjustments to strategies or content
- Represent the Global Regulatory Affairs (GRA) function at key global health authority meetings and with external stakeholders
- Leverage regulatory health authorities (e.g. FDA, EMA, key national competent authorities), industry trade associations’, and other relevant organizations’ insights to advance Vifor’s position related to regulatory and safety policy
- Provide strategic Regulatory leadership either directly or via mentoring and guidance of team members:
Guidance to internal brand, product and project teams on strategy, LCM, data requirements and label development
Planning for new development and new registration activities in regions of responsibility
Strategy input into integrated development plans enabling optimal product launch and market access.
- Provide support and act as deputy of Head of GRA for specific projects
Take on specific strategic and organizational responsibilities in consultation with Head Global Regulatory Affairs
Functional representative to designated governance committees as assigned (e.g. PRC, DRRB, DSB, GCC)
For this role we are looking for the following requirements:
- BS, BA in a relevant scientific discipline, or BSN/BSc in Nursing, however MA/MS or PhD in life sciences or chemical engineering, or PharmD preferred
- At least 12 years’ experience in Pharmaceutical Industry
- Experience with both biosimilars / generics and innovative products would be a big advantage
- Demonstrated organisational leadership, combined with diplomacy, and an ability to build effective working relationships at all levels throughout the organization to achieve business goals
- Direct experience interacting with national Health Authorities and knowledge of the process for developing and launching products
- Fundamental understanding of the contents of product dossiers and critical attributes of medicinal products for registration
- Excellent verbal and written communication skills in English
Strategic thinker, planner, and implementer with a proven track record practicing sound judgment
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.