Responsible for China NMPA and Japan PMDA registration and renewal activities for IL labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Tech

The Quality/Compliance Manager must have a strong background in quality assurance requirements for a Biotech/Pharmaceutical Manufacturing facility from an operations, facilities, and maintenance perspective. This position is responsible for ensuring that the work conducted by the Facilities team, and its subcontractors perform the work in full accordance with contractual,

About WEX Bank WEX Bank is a leading provider of financial solutions and payment services. We are committed to providing our customers with exceptional service while maintaining the highest standards of compliance and ethical conduct. About the Role We are seeking a highly experienced and skilled Regulatory Compliance Manager 3. The candidate who assumes this role will le

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

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

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