Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Relypsa was founded in 2007 and, in September 2016, became a Vifor Pharma company. More information is available at www.relypsa.com.
Veltassa® (patiromer) for oral suspension was approved in October 2015 for the treatment of hyperkalemia, a condition defined as elevated blood potassium levels that can cause abnormal heart rhythms and even sudden death. A potassium binder, Veltassa is the first new medicine for the treatment of hyperkalemia in more than 50 years and is the first commercialized medicine resulting from Relypsa’s polymer technology platform. Relypsa is committed to ensuring that people living with the burden of hyperkalemia have access to Veltassa.
The Senior Director, Regulatory Affairs will be responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of products. This individual will provide regulatory leadership and a sense of urgency to cross-functional teams responsible for global clinical development programs and ensure effective communication and constructive working relationships with business partners and regulators.
• Develop and direct innovative and effective regulatory strategies in support of assigned products and studies across therapeutic areas
• Work in close collaboration with the head of Regulatory Affairs and international counterparts to integrate all aspects of US and global regulatory strategy
• Hire, mentor, develop and retain staff of regulatory professionals and assign regulatory affairs representatives to serve as US and/or global team and sub-team regulatory leaders as needed
• Serve as advisor on regulatory issues for both marketed and pipeline products; actively collaborate with management and cross functional colleagues within Relypsa and Vifor Pharma (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.)
• Serve as an influential and well respected spokesperson with staff at FDA, including leading meetings and team preparation.
• Provide expert regulatory affairs review, input, opportunity and risk assessment into confidential, strategic and often complex initiatives; ability to manage through ambiguity and drive consensus
• Minimum Bachelor’s Degree in a related discipline or equivalent experience (advanced degree preferred)
• At least 12 years in pharmaceutical industry regulatory affairs, including experience in leading regulatory teams. Extensive clinical regulatory experience will be strongly prioritized.
• Strong knowledge of clinical drug development and regulatory policy; excellent scientific and business judgment
• Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds
• Ability to manage complex issues and coordinate multiple projects simultaneously
• Ability to build team relationships and collaborate in a global team environment at all levels of the organization
• Strong interpersonal, communication and leadership skills
• Proven track record practicing sound judgment
• Highly conversant and knowledgeable of new and emerging regulations and guidance. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.
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 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.