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.
- Lead the US regulatory group (currently 7+ staff members, including consultants), which is comprised of CMC, clinical, advertising & promotion and regulatory operations functions.
- Manage the US regulatory group activities, budget and staff including identifying, hiring and training additional staff as needed to develop Vifor’s US FDA center of expertise.Provide coaching and mentoring to develop group members knowledge and capabilities.
- Oversees regulatory aspects of submissions and communications with FDA by departmental staff for Relypsa products.Manage timelines and resources to achieve stated objectives, ensuring tracking tools and regulatory databases are maintained up to date.
- Coordinate or support US FDA contacts for other global regulatory groups within Vifor corporate group
- Represent US RA group and US/FDA perspectives within the Vifor global regulatory leadership. Work in close collaboration with Vifor global functions to integrate all aspects of US and global regulatory strategy
- Ensure that the interactions between Regulatory and other departments are managed optimally.Work in close collaboration with Relypsa functional heads to integrate regulatory within site processes and to contribute to cross-site initiatives.
- Provide strategic regulatory support to internal brand, product and project teams.Pro-actively monitors the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape and assesses the potential impact on the regulatory and/or business strategy and planning.
- Develop regulatory, strategic, and compliance plans for maximizing the commercial aspects for the marketing of Relypsa's products.
- Serve as an influential and well respected spokesperson with staff at FDA, including leading meetings and team preparation.
- Contributes to the development and implementation of processes and procedures relevant to the operations of the regulatory function and its interactions with internal stakeholders.
Requirements / Qualifications:
- BS, BA in a relevant discipline, or BSN
- At least 10 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/SM or PhD in life sciences or chemical engineering, or PharmD preferred.
- Experience in an international company with more than one marketed product
- Demonstrated strong and broad knowledge in one or more of the following areas:
- CMC drug development and production in various areas (small molecules, polymer, biotech, etc.)
- Clinical development of products through all stages including pre-approval and post-approval research and label management,
- Support of Medical Affairs and commercial activities for approved products within the US market, including recent regulatory experience in advertising and promotion
- Excellent listening, verbal and written communication and presentation skills
- Strategic thinker, planner, and implementer with a proven track record practicing sound judgment
- Excellent organizational skills, with an ability to prioritize and to manage complex issues and coordinate multiple projects simultaneously
- Demonstrated organisational leadership, combined with diplomacy, and an ability to build effective working relationships at all levels throughout the organization to achieve business goals
- Capability to 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; 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.