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...
If the answers to these questions were yes; then this Director Quality Assurance and Regulatory Affairs opportunity with an outstanding Medical Device organisation in Illinois might be the change you need. Ensures compliance with regulatory standards and readiness for inspections. Independently revi...
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 quality...
Director Regulatory Affairs, Global Regulatory Strategy. Director Regulatory Affairs, Global Regulatory Strategy. ...
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...
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...
As the Senior Director Regulatory Affairs, Advanced Surgery you will be responsible for global strategic direction and performance (strategy and execution) of the Regulatory Affairs (RA) function within the division including development, implementation and management of global regulatory strategies...
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 quality...
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 quality...
The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s). E...
The Director, Abbott Nutrition Regulatory Affairs is responsible for combining scientific, regulatory, and business knowledge to ensure our nutritional product portfolio in LATAM meets the necessary regulatory requirements, products are approved for placement on market, and that registrations are ma...
The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s). E...
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...
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. ...
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timeli...
The Quality Program Manager is responsible for ensuring the success of major, multi-faceted and highly complex programs at the site, regional and global level, which support the strategic efforts of the company. Title: Program Manager-Quality-. Manages cost, schedule, and performance of component pr...
Global Regulatory Affairs Strategy roles (U. Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Assist Re...
The Executive Medical Director is responsible for the safety strategy for Hematology late-stage oncology portfolio, and to supervise, manage and mentor the safety physicians (Group MDs, Senior MDs and medical directors) and the MSE staff supporting the hematology in the Oncology TA. The Executive Me...
Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy. Assures that regulatory strategies defined with...
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...
Joule has a contract opening for a Regulatory Affairs Ops Specialist II that will be responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of...
Sr Specialist, Regulatory Affairs is responsible for the coordination and preparation of regulatory documents/deliverables/packages to support Establishment Registrations and Listings for Drugs for the US market. Compile and submit, in a timely manner regulatory deliverables in support of Structured...
The Associate, Regulatory Affairs Submission Management, manages low to medium-impact submission projects involving multiple cross-functional regulatory submission teams. Job Title: Associate Regulatory Affairs Submission Management. With input from the submission teams, this individual establishes ...
Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of regulatory management. Provides regulatory support and guidance a...