Associate Director of Regulatory Affairs, Combination Products, will be responsible for providing regulatory guidances to devices / combination product development and life cycle management, including generic products, 505B2 NDA products and biosimilars, preparing and reviewing submissions. Prepare ...
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,...
Support the lead regulatory strategy for late-phase oncology programs, ensuring alignment with global regulatory requirements. Minimum of 8 years of industry experience, with at least 4 years in regulatory affairs. Strong technical proficiency in regulatory affairs is crucial. The client is seeking ...
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,...
Associate Director Level: Minimum of 7 years in the pharmaceutical industry, with at least 4 years dedicated to regulatory labeling. Develop and implement regulatory labelling strategies for new product labels and launches. Contribute to or lead strategic initiatives, ensuring compliance and alignme...
Associate Director of Regulatory Affairs, Combination Products, will be responsible for providing regulatory guidances to devices / combination product development and life cycle management, including generic products, 505B2 NDA products and biosimilars, preparing and reviewing submissions. Prepare ...
Abbott Park, Illinois - 60064-3500.Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements,...
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,...
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,...
The Senior Manager Regulatory Affairs is the regulatory expert and is responsible for leading the preparation, documentation and submission of regulatory applications for Sysmex products. The Senior Manager position in Regulatory Affairs leads the regulatory strategy for new and modified Sysmex medi...
This newly created position develops and participates in various tax initiatives and projects. Overall, this is a sole-contributor role with occasional teaming with other tax department members on various projects. Manage the annual research and development credit project. Participates in meetings, ...
Role: Program Manager (Data Transmission). Responsible management/execution of project(s)/ programs assigned. Report the performance of projects/programs to the project team, stakeholders, and leadership. Manage overall portfolio by ensure the prioritization of projects, program and portfolio. ...
Support Fulfillment PMO operations, which may include evaluation of internal customer project requests, project prioritization per strategic business objectives, resource planning, project roadmapping, team metrics and reporting, and collaboration with the Operations EPMO. Projects include systems i...
As a Capital Projects Manager at The Chicago School, you will play a pivotal role in the successful planning, execution, and management of our capital projects. If you are passionate about creating spaces that inspire learning and innovation, and you thrive in a dynamic, fast-paced environment, we i...
The Regulatory Affairs CMC Manager / Sr. Manager is responsible for the on-time filing of high-quality regulatory submissions and for the post-approval maintenance of regulatory dossiers with an emphasis on CMC. Serve as the primary regulatory interface with US FDA manufacturing partners (domestic a...
When you're the best, we're the best.We instill an environment where employees feel engaged, satisfied and able to contribute their unique skills and talents .We provide extensive opportunities for personal and professional development, building both employee competence and organizational capability...
Regulatory Affairs Specialist to work on Cybersecurity related regulations. The individual will also collaborate with regulatory affairs to develop, implement, and maintain software and cybersecurity framework and procedures to maintain and ensure compliance with medical device regulatory requiremen...
Job Summary: Talent Software Services is in search of a Banker - Compliance Analyst for a contract position in Chicago, IL. ...
This role works closely with the Compliance Managers, Legal and Senior Management on confidential and critical matters and provides compliance support to internal stakeholders. Responsible for coordinating and executing regulatory compliance and market conduct initiatives. ...
The Senior Director/Director of Regulatory Affairs, Biopharma, will provide regulatory guidance for (Bio)Pharma product development and tech transfer, especially biosimilars. The successful candidate will develop regulatory strategies for projects and portfolios in BioPharma, contributing to the tra...
The Project Manager is primarily responsible for the planning and execution of the most complex, cross-functional, cross-department and member impact projects across the organization. Partner with executives, operational leaders and process owners to translate vision into an executable plan while ov...
Apply professional project management techniques while building project management tools and methods that are repeatable across the organization and establish a network of internal experts to support the spread of their use. This individual identifies and prioritizes strategic initiatives using anal...
The ideal candidate will work with the Cloud Compliance Operations team to support the execution of Cloud commercial agreements in compliance with internal selling policies. Manage projects to continually map, enhance and improve compliance operations procedures. Experience with compliance operation...
We are looking for a proactive and ambitious Project Manager who is able to successfully run a project that is completed to exceed the expectations of the client. The Project Manager will ensure that the project is completed safely, successfully, and efficiently. We build projects with passion and a...
Title : Contact Center Project Manager/Contact Center Operations Project Manager/Contact Center Operations Manager/Call Center Project Manager/Call Center Technical Project Manager/Call Center Operations Project Manager. Seeking a Project Manager to support our Commercial Airline client within their...