Reporting to the Global Head of Regulatory Affairs in Zurich Switzerland, the Head of U.S. Regulatory Affairs will lead the regulatory affairs department of Vifor Pharma US. The group is responsible for all aspects of regulatory support for Veltassa in the US, but also provides US regulatory expertise and guidance for specified products from the Vifor global portfolio. The individual will lead and further develop this center of excellence for regulatory interactions with the FDA. Currently the U.S. Regulatory Affairs group comprises CMC, clinical development, advertising & promotion and regulatory operations functions. These functions are closely aligned with global functions in a matrix organization, and the individual will work in close alignment with global colleagues. Candidates should have a strong background in supporting commercialized products and not only development stage activities. There is an expectation of some occasional travel.
Requirements / Qualifications:
• BS, BA in a relevant discipline, or BSN • At least 15 years in pharmaceutical or biotech industry in regulatory affairs • Direct management experience leading regulatory teams internally and with FDA and other health authorities • Proficiency in Microsoft Word, Excel, PowerPoint, Adobe Acrobat
• MA/MS or PhD in life sciences or chemical engineering, or PharmD preferred. • Experience in an international company with more than one marketed product • Demonstrated experience and strong knowledge in support of Medical Affairs and commercial activities for approved products within the US market, including recent regulatory experience in advertising and promotion
• Demonstrated organisational leadership, combined with executive presence and diplomacy, and an ability to build effective working relationships and successfully influence at all levels across organizations to achieve business goals • Strategic thinker, planner, and implementer with a proven track record practicing sound and timely judgment • Strong team leadership skills with the ability to foster high-performing teams (both functionally and cross-functionally) • Excellent listening, verbal and written communication and presentation skills • Excellent organizational skills, with an ability to prioritize and to manage complex issues and coordinate multiple projects simultaneously • Capability to create, lead and direct implementation of operational strategies through management of organisation and teams • Examines and understands issues from multiple perspectives or points of view, readily sees inter-relationships and cause-and-effect relationships; critical thinker that takes a systematic approach to successfully resolving all issues
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.
What you can expect of us
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.
Open, safe and inclusive culture that fosters creativity and unleashes individual potential, whether in laboratories, manufacturing sites, in the field, or offices
Learning opportunities that enhances your skill set focused on business and personal effectiveness, leadership and management skills, and much more
Flexible workplace environment, home office opportunities, competitive vacation entitlement
Attractive ﬁnancial participation schemes, adapted regionally, that provide employees with additional security for every life situation, including: Pension plans, participation schemes, and savings plans
Join Vifor Pharma Talent Community
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.