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...
Regulatory Affairs Ops Specialist. 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 Company’s products. Compile and submit, in a time...
Regulatory Affairs Ops Specialist I. Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types. Creating timelines for regulatory filings. Overseeing authoring and reviewing of regulatory documents. ...
Regulatory Affairs Specialist II. Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments. Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for produ...
Regulatory Affairs Ops Specialist I. Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types. Creating timelines for regulatory filings. Overseeing authoring and reviewing of regulatory documents. ...
Represent international RA and demonstrate leadership in complex product development strategies by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission. Review protocols and...
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. ...
Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types Creating timelines for regulatory filings Providing and maintain templates for authoring. Overseeing authoring and reviewing of regulatory documents QC submission documents. Ide...
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...
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...
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, ...
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 Baxter’s products. Compile and submit, in a timely manner, regulatory documents acco...
GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, ICH Regulations. Responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of gener...
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...
Under supervision responsible for implementing global regulatory strategies, acquiring and maintaining marketing authorizations for product(s) and communicating general regulatory requirements in support of licensing Baxter’s products. Represent or lead Regulatory Affairs in small project teams. Wit...
The Manager position in Regulatory Affairs contributes to the regulatory strategy for new and modified Sysmex medical device products. The Manager Regulatory Affairs is responsible for the preparation, documentation and submission of regulatory applications for Sysmex products. We currently have a g...
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 Program Manager, Clinical Supply Chain Management’s primary responsibility is to manage the clinical supply chain for early phase (uncomplicated) compounds. Define and implement a global clinical supply strategy, in conjunction with mentor or experienced Drug Supply Manager. Matrix managem...
Mastery of program and project management disciplines, including development of program/project plans, assessment and mitigation of risk, effective meeting management and tracking actions and issues. Must have program or project management certification (PMP or PgMP). ...
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,...
We are seeking a dynamic Regulatory & Compliance Specialist with a strong legal background and expertise in gaming and cannabis regulations to join our team. Regulatory Compliance: Stay abreast of and interpret gaming and cannabis regulations at the local, state/provincial, and federal levels, ensur...
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...
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...
MCR’s Rates and Regulatory Services consulting practice provides customized solutions for regulatory strategies, rate case processes and rate relief proceedings. MCR is seeking an ambitious, committed, and skilled Regulatory Manager with a passion for superior client service to support rate and regu...
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...