Ensures high quality and on time submissions, including for INDs, IMPDs, CTAs and BLAs, that align with company strategies and Health Authority requirements. This includes planning, coordination and tracking the CMC dossier towards submission milestones. Interact with cross functional departments to ensure deliverables are met according to the corporate goals. Coordinate

Teaching a full academic load; regular publication of significant scholarly work; if ultimately appointed as a tenured member of the CLS Faculty, active participation in faculty affairs, including membership on standing faculty committees in consideration of a wide range of issues including faculty appointments and curricular modifications. J.D. (or J.D. equivalent); or P

Regulatory Affairs Consultant must have an understanding of the organization's consulting models and methodologies, as well as good knowledge of what services PC provides. The Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the timely performance of wo

We are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote. Key Deliverables in the role Manage the local submissions (as

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Senior Regulatory Affairs Associate must understand the organization's consulting models and methodologies, as well having as good knowledge of what services PC provides. The Senior Regulatory Affairs Associate must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the ti

1. Should have experience in eCTD, NeeS and paper formats. 2. Working experience in all major emerging countries (EU, GCC, US, ASEAN etc.) 3. Compilation, publishing, and technical quality control of Regulatory submissions including technical troubleshooting to ensure issues with submissions are resolved and deadlines met. 4.Should have experience in handling submission g

The Regulatory Affairs Specialist ensures compliance with all applicable animal feed and pet food regulations related to the import of raw materials and export of finished products. The Regulatory Affairs Specialist Import/Export is responsible to provide regulatory guidance on assigned projects, to coordinate the timely preparation and submission of technical information

Security Consultant Job ID 2024 4591 Job Location US IL Chicago Overview Affiliated Engineers, Inc. (AEI) is a leading, multidisciplinary consulting engineering firm and collaborative community of over 800 employees who plan, design, and deliver high performance, innovative, and holistic engineering solutions positively impacting society and advancing humankind . Recogniz

A day in the life of a Regulatory Specialist at Hackensack Meridian Health includes Organizes and maintains, in audit ready condition at all times, the regulatory binder (paper or electronic); files essential documents, obtains signatures for delegation logs, training logs and other essential study documents. Reviews sponsor template and site level Informed Consent Forms

Support the Sr. Director of Proposals as required; Lead a team of proposal and business development professionals Serves as Proposal Manager on largest, highest priority, and most complex proposals. Leads, directs, and assists proposal volume leads, and l eads other supporting Proposal Managers and Proposal Coordinators Leads the MTSI proposal development process across t

The Compliance Officer reflects the mission and vision of Cook County Health (CCH) adheres to the organization's Code of Conduct and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards. The Compliance Officer is responsible for the ongoing development, implementation, maintenanc

The ideal candidate will be located in Washington, D.C. As the Director of Federal Government Affairs at bioMerieux, you will be a pivotal member of our Government and Public Affairs team, responsible for monitoring the U.S. policy environment relevant to our priority areas of focus. Your role will involve analysis of relevant policies and proposed legislation, creating r

Symetra has an exciting opportunity to join our team as an Assistant Director of Compliance ! About the role Symetra is seeking an Assistant Director Compliance Financial Crimes to join our Enterprise Compliance Department. The position will lead and oversee the Financial Crimes function, its initiatives and responsibilities across the company as well as represent Corpora

The Department of Political Science at the University of California at Davis invites applications for one or more temporary teaching positions in the fields of International Relations, Comparative Politics, American Politics and/or Political Theory for the 2024 2025 academic year. Availability of this position depends upon final administrative approval and the teaching ne