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