This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements. The Director, Regulatory Affairs will head the Regulatory function at MaxCyte. Utilizes knowledge of regul...
The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position involves interpreting ...
Working with other Regulatory Affairs Directors, develops and maintains an inventory of all compliance and regulatory requirements related to the organization's major risk areas, including: academics, career services, enrollment management, licensing, student finance, student services. Reports areas...
Assist in the refinement and enforcement of Regulatory policies with particular emphasis on compliance to the company's Quality System, external regulatory standards (e. Canada pharmaceutical or medical device Regulatory Affairs. The Manager, Regulatory Affairs will provide support to Operations...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. ...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. ...
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
Director of Global Regulatory Affairs - Permanent - Maryland, US. Proclinical is seeking a Director of Global Regulatory Affairs, Development Strategy to lead the U. Director of Global Regulatory Affairs' responsibilities will be:. In this key role, the successful candidate develop and implement reg...
Working with other Regulatory Affairs Directors, develops and maintains an inventory of all compliance and regulatory requirements related to the organization's major risk areas, including: academics, career services, enrollment management, licensing, student finance, student services. Reports areas...
This role will report as a Program Manager to a Senior Program Manager and EODAS Portfolio Lead in support of the program organization. Primary responsibilities are the management of cost, schedule, and technical performance of company programs or subsystems and include, but are not limited to: * Su...
Minimum 1+ years pharmacy experience required.Exciting Opportunity at a Long-Term Care Pharmacy in Columbia, Maryland!.Our partnering pharmacy in Columbia, Maryland, is seeking dedicated professionals to join their team.This is a fantastic opportunity to work in a supportive environment and make a m...
Are you a skilled pharmacist with clinical expertise and strong communication abilities?. Were looking for an experienced PV1 Pharmacist to join our dynamic team and make an immediate impact!. This is an amazing opportunity for pharmacists seeking a flexible and engaging work environment with the po...
The Senior Regulatory Compliance Analyst will conduct independent analysis for complicated, high level regulatory inquiries and provide interpretation of regulatory rules and guidelines to demonstrate compliance with state and federal requirements. Frequent interaction with all internal areas especi...
The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements. The Director, Regulatory Affairs will head the Regulatory function at MaxCyte. Utilizes knowledge of regul...
The pharmacist also works closely with the rest of the adult night shift pharmacist team (typically 5 pharmacists including the ED pharmacist) to ensure pharmacy division operations are running well. We're hiring a Clinical Pharmacist IIA (Night - ED/Inpatient)! Join our team and receive a night shi...
The pharmacist also works closely with the rest of the adult night shift pharmacist team (typically 5 pharmacists including the ED pharmacist) to ensure pharmacy division operations are running well. We're hiring a Clinical Pharmacist IIA (Night - ED/Inpatient)! Join our team and receive a night shi...
The Clinical Pharmacist II in Neurology provides clinical pharmacy services for the patients on Zayed 12 including the Epilepsy Monitoring Unit, Brain Rescue Unit, and Neuro IMC beds serving as the drug expert helping to manage the complex pharmacotherapy regimen of each patient. The clinical pharma...
Under the supervision of the Director of Compliance for Education, Training, & Regulatory Monitoring, the analyst will assist with the management, development, implementation and monitoring processes to ensure compliance with federal and state laws and regulations affecting the University of Mar...
As the Program Management Trade Licensing and Compliance Lead, you will help guide the mission areas by managing and assessing classification and jurisdiction and specially designed aspects of program hardware, software, technical data, and services enumerated under the ITAR, EAR, and Customs Regula...
Develops Compliance Hotline statistical data for reporting to the Audit and Compliance Committee of the Board of Directors, the Executive Compliance Committee, the Affiliate Compliance Officer Committees and other meetings as requested. Works collaboratively with the Compliance Director in compiling...
CLASSIFICATION TITLE: COMPLIANCE SPECIALIST. Under direction the Compliance Specialist communicates with jurisdiction clients regarding bids and proposals and communicates with certified SLBEs and Minority and Women Business Enterprises (MWBE) regarding opportunities. Monitors participation of SLBEs...
Ability to produce deliverables and client engagement documentation related to executing successful compliance monitoring activities, by supporting the planning, development, and implementation of audit/compliance programs. Minimum 1-3 years of professional experience in public policy, public health...