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Develop business cases and recommendations through data driven approach and drive execution of action plans. Drive trade compliance change management and continuous improvement while providing input t...
Responsible for ensuring compliance with all applicable provisions of the Quality Management System, as well as the regulations. Assures that inspection / audit responses are timely and appropriate to...
Provides the business with advice about acceptable behaviour and practices in relation to the interpretation of external and internal rules, in collaboration with second line Compliance and Risk colle...
Oversee the development and execution of a comprehensive organization risk control self-assessment (RCSA) process, common risk taxonomy, and use of key risk indicators (KRIs), working in close partner...
Act as a quality reviewer for the development of functional group controlled documents and assist functional groups in management and processing of controlled documents...
This position will be responsible for the review and submission of advertising/promotional materials in compliance with FDA regulations and guidance documents. This position will also support addition...
In this role, you will primarily support the Global Trade Compliance team in developing and overseeing all aspects of regulatory compliance related to Ocean, Dray, Consolidation and Customs Compliance...
Identify and highlight risks and issues within project(s) and escalate appropriately. Identify, develop, and implement effective mitigation and escalation strategies for projects to address risks and...
Create and manage a targeted digital risk awareness-training program for all employees, contractors and approved system users, and establish metrics to measure the effectiveness of this digital risk t...
Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP and policies and pr...
Develop all proposal materials including but not limited to: proposal outline, compliance matrix, proposal management plan, proposal kick-off meeting materials, storyboard and writing plans...
Ensure integration of enterprise architecture, security & compliance requirements into IT services & projects. Manage relationships with Product Owners from Agile Scrum Teams...
The role will support tactical execution of the marketing strategy focused on end to end joint review committee (JRC) management, and strategic management of commercial sponsorship requests with a str...
Demonstrated knowledge of global health authorities, regulations, product approval and life-cycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices...