Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities. ...
The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US regulatory filin...
Key Responsibilities:Develop and implement regulatory strategies for global medical device clearances and approvalsManage regulatory submissions and communications with FDA and EU notified bodiesProvide regulatory guidance to cross-functional teams throughout the product lifecycleRequired Qualificat...
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...
Regulatory Affairs Manager to join our Regulatory Team. Strong proven hands-on Regulatory Affairs experience and knowledge of regulatory submission requirements for global filings is required. Responsible for development of US and global regulatory strategy, identifying key regulatory issues, delive...
Liaise with colleagues in Regulatory Affairs therapeutics teams, company local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, Regulatory Affairs III. Sen...
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...
Experience in representing regulatory affairs on development project teams. Background in Clinical regulatory affairs: Clinical study reports, protocols, Investigator Brochure, investigator updates, ICF, IRB, site initiation, sponsor/investigator responsibilities etc. Regulatory Affairs Certificatio...
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 Regulatory Staff by id...
Under the direction of the appropriate level manager or administrator, the Accessibility and Compliance Instructional Support Specialist performs a variety of specialized duties involved in identifying and recommending potential solutions for accessibility barriers based on current applicable guidel...
Credentialing and Compliance Manager. Job Opening ID: 28162Reports To: Administrative Supervisor 1Working Title: Credentialing and Compliance ManagerDepartment: Counseling CenterBargaining Unit: 99FLSA: Non-ExemptPayroll Job Code: 007376Job Location: UCI Campus- IrvinePercent of Time: 100%Work Sched...
Are used on a temporary basis for a specific project or projects. Works directly with the Supervisor in the development and coordination of the project budget, delivery expectations, and tracking the status of project expectations and results. Assists the Supervisor with all phases of a project. Pro...
A company is looking for a Principal Compliance Program Manager for Federal Programs with a security clearance. ...
A company is looking for a 340B Audit-Comp Analyst to assist with the coordination of the 340B Drug Pricing Program across its health system. ...
A company is looking for a Regulatory Compliance Specialist 4 to support and implement audit programs for cloud infrastructure. ...
A company is looking for a Senior Research Project Manager to oversee the creation and integration of a key governance forum within its commercialization model. ...
A company is looking for a Regulatory Compliance Manager to oversee and monitor its regulatory change management program. ...
A company is looking for a Project Manager, Client Services to assist with the management of eDiscovery cases. ...
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A company is looking for a Compliance Medicare Marketing Manager to oversee marketing compliance efforts in a highly regulated environment. ...
A company is looking for a Senior Medicare Communications Compliance Specialist to support regulatory requirements associated with Medicare materials and sales compliance. ...
A company is looking for a Regulatory Affairs and Compliance Director (Remote). ...
A company is looking for a Senior Ethics and Compliance Specialist to join their Corporate Compliance team. ...