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

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

WEX Inc. (NYSE WEX) is a leading provider of business to business physical, digital, and virtual card payment solutions. WEX's fleet, corporate, and health payment solutions provide its customers comprising small businesses, large fleets, and corporations with unparalleled security and control across a wide spectrum of business sectors. We are executing against a multi pr

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

Vaco Boston has partnered with a global investment manager that is seeking a Director of Compliance. Responsibilities Preparing materials and briefing notes for the chair of the Investment Committee. Staying current on regulatory developments applicable to investment advisers, mutual funds, and broker/dealers, including the impact of banking regulations and non US regulat

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

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

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

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

Assists the Research Integrity Officer (RIO) and other team members with research integrity investigations. Receives, investigates, documents, and tracks research integrity complaints from workforce members, patients and/or family members. Coordinates with stakeholders, including HR, to develop and implement timely responses to issue reported including corrective action p