Communicate directly with sites to enable start-up and maintain an active collaboration with sitesIdentify, communicate, and resolve issuesEnsure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems. ...
Work collaboratively with Regulatory Affairs and contributing cross-functional team members to create and maintain regulatory submission project plans, manage deliverable timelines and activities, and works with the Regulatory lead to ensure issues, risks, or impact due to changes in strategy and/ o...
Quality Associate Director of Regulatory Intelligence. The Quality Associate Director Regulatory Intelligence. Promote regulatory compliance expertise, both externally and internally, by collaborating with colleagues and project teams in support of Labcorp presentations and journal publications, and...
Donnelley Financial Solutions (DFIN) is a leader in risk and compliance solutions, providing insightful technology, industry expertise and data insights to clients across the globe.We’re here to help you make smarter decisions with insightful technology, industry expertise and data insights at every...
Compliance at Gemini is a team dedicated to managing the next generation of financial and regulatory compliance in a complex and evolving regulatory environment. Senior Associate, Regulatory Compliance (Credit Card). In this role, you will support senior Compliance leadership across all areas of reg...
Under the direction of the Senior Director or Executive Director, Global Regulatory Affairs provides strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activ...
Ensure security controls are operating effectively, develop and recommend corrective actions for addressing non-compliance. Perform ongoing third-party security assessments to ensure compliance with GT and University System of Georgia (USG) policies. ...
The Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the company’s line of products. Regulatory Affairs Specialist II - Hannah. This includes the preparation of regulatory documentation for submission to regulat...
Accounts Receivable Specialist. Revenue Cycle Management Division! This Accounts Receivable Specialist is responsible for the validation of Advanced Beneficiary Notices (ABN) for Medicare. ...
Assists and supports the organization in complying with, as well as the ongoing preparation and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies. May serve as point of contact for interactions with regulatory agencies for defined matters. Performs t...
Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements. Represents CMC RA in project team meetings and provides regulatory guidance and perspective to t...
Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Reviews regulatory impact assessments drafted by RA staff for manufacturing and product changes for notification to regulatory agencies. Prepares regulatory plans and prepares needed regulatory submissions and as...
The project manager will not only work with the leadership team to plan and deploy new projects but to support the ongoing operational management of recurring projects. The Senior Project Manager is expected to successfully drive projects and initiatives to completion with accuracy and efficiency. W...
BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA i...
As the new SVP of Regulatory Affairs, the successful candidate will lead the regulatory team in developing and implementing global regulatory strategies for the company's pipeline products as they expand beyond the USA. Develop global regulatory strategies to gain earliest possible regulatory approv...
Become an authority on all things IT audit and compliance. Translate business and control requirements into the design of features and enhancements in our compliance tools. At HubSpot, fair compensation practices isn’t just about checking off the box for legal compliance. ...
Regulatory Operations Publishing Specialist contributes to daily operations activities for preparation of regulatory submissions and collaborates with interdisciplinary teams and Regulatory Affairs staff in the management of submission components and tracking of deliverables. Regulatory Operations P...
Ensures compliance with Deringer specific policies and procedures, based on department’s specific tasks. Previous technical/compliance background and language skills are a plus. ...
The Payroll & Tax Compliance analyst will be responsible for the research and evaluation of payroll tax regulatory changes to ensure that the R365 payroll platform meets the needs of our customers expectations for US payroll tax compliance. They will partner with our internal teams to evaluate and d...
Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product ...
With the Carolina Complete Health Compliance team, you will develop, implement, and perform compliance auditing, monitoring and reporting activities based on established program, policies, and practices to ensure and maintain compliance with federal, state, and local regulatory and contractual requi...
Work with Department Manager to assist with the continuous process improvement of the department. Strong background in process design and project management. ...
Gartner analysts are industry thought leaders who create must-have research and provide advice to world-leading organizations. Analysts possess a keen eye for identifying gaps, problems and solutions within the market they serve, and help clients make better decisions relative to their highest busin...
This exceptional growth has led to the appointment of a new Director of Regulatory Affairs, who will play a pivotal role in orchestrating the filing of a new IND. Lead all aspects of submission publishing and archiving activities globally associated with generating highly complex electronic submissi...