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 Relypsa. 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. The position is located in Redwood City and 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
As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs and RSUs reflect Relypsa’s high regard for our employees.
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Relypsa is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.