Manager, Regulatory Affairs (promotional material) - Redwood City, CA | Biospace
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Manager, Regulatory Affairs (promotional material)

Relypsa Inc.

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Location:
Redwood City, CA
Posted Date:
8/9/2017
Position Type:
Full time
Job Code:
533
Salary:
DOE
Required Education:
Other
Areas of Expertise Desired:

Job Description

Company Overview

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.

Product Overview

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®.

Position Summary:  

The Manager, Regulatory Affairs will have broad Regulatory responsibilities and serve as the regulatory lead for designated project teams.

Position Responsibilities:

•   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; maintain these applications as required
•   Provide regulatory support to affiliate and international projects as needed, including supporting international filings, and 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

Requirements

•   BS or higher degree in science or law, or equivalent, with at least 5 years of experience in Regulatory Affairs
•   Experience in preparation and submission of CTAs and amendments
•   Experience in preparation and submission of a NDA/MAA is preferred but not required
•   Strong knowledge of ICH requirements and guidelines and CTA/IND/MAA/NDA/eCTD requirements
•   Experience with preparation of documentation to support regulatory agency interactions
•   Manages (initiates, directs and completes) defined projects within agreed-upon parameters and timelines
•   Shows strong initiative and drive. Must be an organized self-starter who is able to anticipate departmental needs
•   Excellent interpersonal and communication skills are essential. Ability to work successfully within a cross-functional team
•   Must be able and willing to work in a fast-paced environment while handling multiple priorities. Must be flexible, detail-oriented, and possess excellent analytical and problem-solving skills
•   Proficiency in Microsoft Word, Excel, PowerPoint and Adobe Acrobat

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, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.