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...
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...
Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and pos...
Title: Regulatory Affairs Ops Specialist I. Managing the preparation of regulatory submissions for IND, ANDA, NDA, K, Clientrom, and other electronic submission types. Creating timelines for regulatory filings. Overseeing authoring and reviewing of regulatory documents. ...
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...
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...
The International Regulatory Specialist is responsible for providing regulatory support to Rust-Oleum's international business. Be part of a regulatory team that supports a >. ...
The position of Regulatory Affairs Specialist II (Medical Events) is within our Infectious Disease business unit located in Lake Forest, IL. The documentation of the work of the Medical Event Analyst is scrutinized by the Regulatory. Failure to properly evaluate or report complaints could result in ...
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. ...
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...
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...
The International Regulatory Specialist is responsible for providing regulatory support to Rust-Oleum’s international business. Be part of a regulatory team that supports a >. ...
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
Staff Regulatory Affairs Specialist,. Staff Regulatory Affairs Specialist. Communicate with regulatory agencies regarding pre-submission strategies/regulatory pathway development, submissions, and follow-up on submissions in review. You will research requirements (local, national, international), ap...
The International Regulatory Specialist is responsible for providing regulatory support to Rust-Oleum's international business. Be part of a regulatory team that supports a >. ...
Title: Regulatory Affairs Ops Specialist II. 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 Client’s products. Compile and submit, ...
The position of Regulatory Affairs Specialist II (Medical Events) is within our Infectious Disease business unit located in Lake Forest, IL. The documentation of the work of the Medical Event Analyst is scrutinized by the Regulatory. Failure to properly evaluate or report complaints could result in ...
Handling data management and retrieval of regulatory documents. Preparing and submitting US regulatory filings on time and in compliance. Staying current with regulations and providing expertise in regulatory affairs. Training team members and ensuring regulatory compliance. ...
Regulatory Specialist to join our team and support the Flavors business in North America. In this role, you will assure compliance of Sensient Technologies products with appropriate regulations and serve as a regulatory resource to internal and external customers. Adheres to regulatory procedures to...
Project managers plan and designate project resources, prepare budgets,. Years of Project Manager Experience in the Commercial HVAC Market and. Manage the day-to-day project activities and resources and chairs the project management team meetings. Years of Project Manager Experience in the Commercia...
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 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...
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...
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...
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...