Partnering with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings , to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory stra...
Under the direction of the Senior Director or Executive Director, Global Regulatory Affairs provides strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activ...
Donnelley Financial Solutions (DFIN) is a leader in risk and compliance solutions, providing insightful technology, industry expertise and data insights to clients across the globe.We’re here to help you make smarter decisions with insightful technology, industry expertise and data insights at every...
Communicate directly with sites to enable start-up and maintain an active collaboration with sitesIdentify, communicate, and resolve issuesEnsure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems. ...
The QA Associate Director, Regulatory Intelligence monitors the environment for regulatory compliance intelligence in the company's areas of interest to ensure that current awareness is maintained across the organization and, where necessary, that company procedures are introduced or adapted to resp...
Medicaid and CHIP Managed Care Compliance Specialist. ...
The Strategist (Sr Manager) works in a highly highly matrixed, global product team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with other PDT BU functions and relevant Takeda R&D functions to provide an effective and...
This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest qua...
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
The Senior Data Analyst will join the Square Compliance Analytics team to transform Square Compliance into an global data-driven Compliance organization. You will manage critical regulatory data requests for multiple markets, help redesign our global reporting strategy, deliver strategic insights to...
Participate in activities to ensure departmental compliance to all Federal, State, Local and Company regulatory requirements. ...
As the Senior Director of Regulatory Affairs, you will spearhead the development and execution of a dynamic global regulatory strategy for food and biopesticide/biostimulant products, facilitating business growth through gaining market permissibility while ensuring compliance and risk management. Re...
Typical projects range from preparing air permit applications, conducting compliance audits, preparing emission reports, conducting air quality applicability assessments, program development, regulatory analysis and reporting, and database solutions for air quality compliance requirements at the loc...
Interface with suppliers along with industry partners to ensure products and components meet regulatory compliance. Produce and maintain required compliance certificates, test reports to show conformance to regulatory requirements. Support regulatory compliance process improvement activities . ...
Become an authority on all things IT audit and compliance. Translate business and control requirements into the design of features and enhancements in our compliance tools. At HubSpot, fair compensation practices isn’t just about checking off the box for legal compliance. ...
Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product ...
Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements. Represents CMC RA in project team meetings and provides regulatory guidance and perspective to t...
The Project Manager II handles more complex projects with a greater degree of independence than a Project Manager I. Manage complex project activities for multiple projects across all project phases. Serve as a mentor to Project Coordinators and Project Manager I roles. Project Manager II, Global PM...
The Senior Project Manager will manage projects and provide project support across Gartner’s Power of the Profession Awards Program, the Supply Chain Top 25 Program and other ongoing research projects conducted by the Supply Chain Programs Team. Project Manager will work with supply chain experts an...
Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Reviews regulatory impact assessments drafted by RA staff for manufacturing and product changes for notification to regulatory agencies. Prepares regulatory plans and prepares needed regulatory submissions and as...
The Business Systems Project Manager is responsible for user support, design, enhancement, triage, resolution, and solution for system-related issues and projects. The Acquisition Services Technology, Projects, and Systems (TPS) Team provides NREL, the OCFO and Acquisition Services the data analytic...
We are inviting professionals in high-growth industries who are thinking about their next move or looking for a new opportunity to join our expanding talent pool.The Marlee Talent Pool is a pilot project designed to:.Help job seekers get discovered by our partners based on their anticipated hiring n...
As a Regulatory Data Sales Specialist, you will be responsible for continuing to grow Bloomberg's hugely successful Regulatory Data franchise throughout the Americas market. Over the years Bloomberg has developed Regulatory & Accounting Products that combine high-quality data, sophisticated analytic...
The Senior Manager, Medical Strategy (Oncology) will be a key member of the Medical Affairs team reporting to the Executive Director, Medical Affairs Strategy. This individual will lead program coordination with Clinical Development leadership to ensure alignment between Medical Affairs, Advocacy, T...
You have created and managed project risk registers based on your knowledge of the project management lifecycle combined with technical knowledge of software deployment projects. The Technical Project Manager role will give you the opportunity to: . You have built project plans based on your kn...