The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
Position: Regulatory Affairs Manager. Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with develo...
Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicab...
The Manager of Regulatory Affairs will lead the regulatory strategy and submission processes for Chemistry, Manufacturing, and Controls (CMC) associated with Abbreviated New Drug Applications (ANDAs) and generic products. Minimum 5 years of experience in regulatory affairs within the pharmaceutical ...
Manger, Regulatory Affairs will be the Regulatory Lead for providing technical regulatory input to cross-functional project teams for assigned early development project activities. This person will ensure that all regulatory requirements/commitments are met with respect to regulatory submissions, as...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
As the Manager of Regulatory Affairs, this role advises the research, creative, application and commercial departments or customers on the safe use, regulatory compliance, regulatory strategy or advocacy for ingredients and products. In a regulatory landscape that is continuously evolving and with o...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
Manger, Regulatory Affairs will be the Regulatory Lead for providing technical regulatory input to cross-functional project teams for assigned early development project activities. This person will ensure that all regulatory requirements/commitments are met with respect to regulatory submissions, as...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with the development of assigned regulatory opera...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
Supervise, review and approval of labeling for marketed products Track applications through FDA reviewing divisions Work with project associate on compilation of information and supportive documentation for FDA briefing packages Work with project leader and team to draft FDA meeting requests and sup...
Position: Regulatory Affairs Manager. Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with develo...
Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with the development of assigned regulatory opera...
The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. A minimum of 4 years in IV...
The Manager will collaborate closely with the Director and VP of Regulatory Affairs, focusing on tasks such as regulatory submissions, initiating and reviewing change controls, and managing labeling activities. This role is responsible for preparing and reviewing a variety of regulatory submissions ...
Manager/Associate Director, Regulatory Affairs Strategist. Manager/Associate Director, Regulatory Strategist is responsible for the assigned branded programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development...
The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. A minimum of 4 years in IV...
Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with the development of assigned regulatory opera...
The Regulatory Manager also develops and implements regulatory strategies to support innovation projects and works in anticipation of regulatory developments with the potential to affect the current portfolio and future pipelines. The Regulatory Manager is responsible for assuring that Nestlé Health...
The Sr GPRM works under limited supervision of the regulatory affairs (RA) program lead to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s). Provides input to global program regulatory strategy, includin...