The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in emerging disease areas, (2) for additional devel

Draper is looking for an experienced Government Accounting & Compliance Analyst to join the Government Compliance Team at Draper. This is a highly visible and impactful role that will be relied upon to ensure Draper's business systems are compliant with DFARS regulations and internal policies and procedures. In addition, the successful candidate will apply professional ex

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