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 Manager, Regulatory Affairs will have a clinical trial focus and serve as the regulatory lead for designated project teams.
- Independently manage and contribute to the preparation of Clinical Trial Applications, including developing submission strategies to ensure earliest possible approvals to conduct the studies and directing the CRO in the implementation of these strategies
- Provide regulatory support to affiliate and international projects as needed
- Coordinate the writing or review of responses to regulatory authority questions and provide requested documentation for new marketing applications.
- Review protocols, reports and other supporting documentation (i.e., quality, safety, efficacy, and labeling) to be included in regulatory submissions (e.g., IND, CTA, NDA, MAA) for accuracy and completeness and compliance with applicable regulations and guidance as well as Relypsa SOPs, where appropriate.
- Independently manage routine regulatory submissions (e.g., Annual Reports, DSURs, Investigator Updates, etc.)
- Serve as the regulatory representative for cross-functional project teams with responsibility for developing or contributing to regulatory strategies and requirements in line with corporate objectives and timelines
- Assist with managing regulatory agency interactions, document preparation, co-ordination of meeting rehearsals and minutes
- Contribute to drug safety and pharmacovigilance activities and ensures timely compilation and reporting of safety reports to relevant US and ex-US regulatory authorities
- Coordinate with other Regulatory personnel and personnel from other departments, as required, to complete assigned projects
- Inform Regulatory personnel and personnel in other departments of new regulatory guidance and regulations