of the role Ardelyx is seeking a passionate individual who works with integrity and determination, to make a difference for patients. Reporting to the Vice President and Head of Global Patient Advocacy, the Director of Government Affairs will be responsible for leading and executing the Ardelyx government affairs strategy at the state and federal levels in close alignment

Works as Global Regulatory Leads (GRLs). Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Represents Regulatory at the Global Development Team with relevant line function leaders. Develops and delivers on fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences) to supp

The Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA working within a CMC sub team structure and serving as a member of the GRT. The Senior Manager will a

Maintain significant compliance programs and regulatory agreements, such as but not limited to the compliance program(s), or equivalent, established by Nevada, New Jersey, Mississippi, and Rhode Island. Provide compliance subject matter expert support and advice, as needed, to Company executives on material matters governed by the programs/agreements. Establish a listing

Compile and maintain inventory of the Company's products and services. Compile and maintain inventory of the jurisdictions within which the Company offers its products and services. Compile and maintain laws, regulations, and regulatory guidance governing the Company's business activities. Monitor for and maintain new and revised laws, regulations, and regulatory guidance

Home Based, US The Quality Assurance (QA) Compliance Manager has a high level of knowledge and experience of appropriate GxP compliance and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes to conduct audits and provide expert advice to internal and external clients. To effectively lead, matrix manages, develop, and implement assi

Apply innovative thinking and problem solving to challenges Contribute to testimony creation and write up of research findings Support Voter Education efforts for the 2024 State and Federal elections Communicate with and support AARP RI volunteers in their role as part of our Advocacy Team Research policy issues, draft documents to support our advocacy efforts, participat

Ensures high quality and on time submissions, including for INDs, IMPDs, CTAs and BLAs, that align with company strategies and Health Authority requirements. This includes planning, coordination and tracking the CMC dossier towards submission milestones. Interact with cross functional departments to ensure deliverables are met according to the corporate goals. Coordinate

Responsibilities of this position include, but are not limited to, the following. Represents the company to CBP. Responds to CBP requests for information regarding import transactions. Maintains formal, company wide import export policies, procedures, controls. Maintains company wide Export Management System, ensuring compliance with U.S. export regulations. Updates impor

Develops a state specific strategic vision for the organization that considers organizational priorities, state and local level needs and issues, and feedback from internal and external stakeholders. Mobilizes the state office team of staff and volunteers in the execution of the strategic vision. Collaborates with staff across the organization in support of the state's wo