The Senior Regulatory Specialist responsible for Canadian legislation identifies, collects, and interprets science-based reports, data and regulations in order to prepare documents for government agencies, curate lists and/or develop Environment, Health, Safety, and Transportation (EHS&T) inform...
Which includes: tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying awa...
Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Reviews an...
Review and process entry of HMDA and CRA reportable loans with 100% accuracy into Compliance CRA Wiz system following current regulatory guidelines. Then preparing a HMDA or CRA packet for all identified loans for regulatory purposes. ...
Senior Regulatory Affairs Specialist. Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Work with Regulatory and CFT to improve efficiency in regulatory deliverables. Understand, investigate and evaluate regulatory history/backg...
The successful candidate will be primarily responsible for: Building a collaborative relationship between the program office and functional areas Program performance including P&L, schedule, performance, customer relationships, and forecasting *What You'll Get to Do:* As the Systems and Software Sol...
Are you a compassionate leader eager to steer and elevate a crucial healthcare program? Join Encompass Health, the nation's largest inpatient rehabilitation company, as a Dialysis Program Manager. Dialysis Program Manager Career Opportunity. Recognized for your expertise as a Dialysis Program Manage...
Egencia, an American Express Global Business Travel company is seeking a Senior Program Manager to join our Product & Engineering team. Own the delivery (from inception to go-to-market) of cross functional programs which span across Product & Engineering, Finance, GCO and B2B Excellence. Ide...
The Compliance Specialist will coordinate research compliance activities at the University's lakeside campuses to ensure regulatory compliance in human subjects research and animal research. Compliance with the regulations requires administrative support of the chairperson of the Institutional Revie...
Familiar and capable of performing all responsibilities of the Quality Associate. Subject Matter Expert in one or more specific Quality processes such as. Experience in assuring the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good M...
Familiar and capable of performing all responsibilities of the Quality Associate. Subject Matter Expert in one or more specific Quality processes such as incoming inspection and/or change management and/or records (including batch release). ...
Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which provides independent quality oversight of GxP activities, covering the AbbVie drug, device and cosmetic portfol...
Presents process, strategy and product labeling at Senior level meetings including Regulatory Strategy Review (RSR), Regulatory Strategy Team (RST), Global Regulatory Product Team (GRPT), Labeling Review and Strategy Team (LRST), Executive Leadership Committee (ELC) and joint company meetings for th...
The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. Aligns and maintains effective communication channels with key Medical, Marketing,...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions....
The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. May lead the Labeling Regulatory Strategy Team (LRST), and serv...
The Associate Director, Regulatory Strategic Planning is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business...
This person will also liaise with the enterprise-wide Legal, Compliance and Corporate Risk functions. This individual will support the business compliance and operational risk/control activities within DNA, which may include risk assessment, controls, procedure documentation, process design, control...
Seeking a compliance-minded individual that is comfortable reading regulations and who is able, or willing to learn how to convert legal tax requirements into operational requirements. Facilitates and performs activities required by the Compliance Management System (CMS) for Corporate Tax. In lieu o...
We are seeking a highly skilled Senior Quality Professional to join our team. The ideal candidate will have a robust background in quality management within the pharmaceutical, medical device, or related life sciences industries, particularly in a cGMP/GDP manufacturing environment. This role requir...
Must have some experience in quality control or quality assurance within a regulated manufacturing environment (GMP is preferred). Understanding of quality processes such as incoming inspection and/or change management and/or records (including batch release). ...
Stripe is looking for a program manager to join Core Operations to scale verification updates. This person will work closely with our Operations, Product, Legal & Engineering teams, in addition to multiple other stakeholders across Stripe to build the operational infrastructure enabling successf...
Quality Assurance Specialist – Elk Grove Village, IL. Assist in training staff on quality assurance processes and customer satisfaction best practices. The ideal candidate will focus on ensuring customer satisfaction by analyzing customer surveys, identifying trends in quality data, and implementing...
The surveillance analyst position works directly with the Senior Analyst team leader. Assist in responding to inquiries from Compliance/Supervision. Must have 1-2 years of experience in Compliance, Surveillance and/or Supervision. ...
Supports management in the development, implementation, and maintenance of compliance programs and a culture of compliance. Responsible for maintaining and enhancing department or functional units in support of the overall compliance program components. Maintains and enhances department or functiona...