The Senior Regulatory Operations Specialist position is an integral part of MRM for Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medical, Legal and Regulatory (MLR) g...
The Specialist in Regulatory Affairs will be assigned to the Risk Analysis and Strategy group. Responsible for ensuring regulatory compliance of raw materials, formulas and will handle projects or other responsibilities aligned to make saleable products globally. Gathering, generating, and managing ...
Represent international RA and demonstrate leadership in complex product development strategies by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission. Review protocols and...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
Manager, Regulatory Affairs Compliance and Planning professional will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget. Manager, Regulatory Affairs Compliance and Planning professionalis responsible for driving implementati...
Senior Director, Global Regulatory Affairs Strategy. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsibl...
The Disaster Program Manager supervises the implementation of the disaster services program in Mercer & Middlesex Counties. The Disaster Program Manager will lead and supervise Disaster Program staff and volunteer team responsible for local preparation, response and recovery management as well as ma...
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...
My client is a multinational CDMO looking for a Regulatory Affairs Manager to work with the FDA and their client sites to manufacture generic APIs, drug products, and certain med devices. Looking for a unique approach to Regulatory Affairs? Want to push boundaries and bring life-saving medicine to t...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
The Enrollment or Compliance Representative provides a variety of support to Brokers assisting with all questions they may have. ...
The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidances, and company policies. Develop and maintain positive ra...
Engages in activities to provide independent compliance and operational risk oversight of Front Line Unit or Control Function (FLU/CF) performance and any related third party/vendor relationships in alignment with the Global Compliance - Enterprise Policy, the Operational Risk Management - Enterpris...
The Senior Analyst, Governance, Risk, and Compliance will be a key individual contributor in our Governance, Risk, and Compliance team. The team member will play a key role in maintaining our PCI compliance program, partnering with process owners, external auditors, and other stakeholders in order t...
As a Program Manager you will:. Provide program level guidance and clarity to other technology leaders within the organization. An energetic leader with a proven track record for delivering complex technology programs across a global organization. ...
The Senior Analyst, Governance, Risk, and Compliance will be a key individual contributor in our Governance, Risk, and Compliance team. The team member will play a key role in maintaining our PCI compliance program, partnering with process owners, external auditors, and other stakeholders in order t...
Team Mentoring, Motivating, Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs). Manage and track study budget, project milestones, and timelines throughout the life of the study and perform contract reconciliation at study end...
The Adult Program Manager will report directly to the Clinical Director. This position will direct and manage the daily operation of the adult outpatient counseling program. This includes: providing administrative supervision to staff, managing quality assurance of services provided and documentatio...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
A rapidly growing biotech/medical device client of X4 Life Sciences is looking for 2 Regulatory Affairs Managers to join their fast-paced organization. One manager (Major Markets) will focus on EU, US and Canada regulations and the other manager (International Markets) will focus on meeting internat...
Reporting to the Director of Client Services/Labor Relations this one-year term position will be the primary project manager project manager for collective bargaining negotiations Responsibilities include facilitating charter creations, developing comprehensive project plans, assembling stakeholders...
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
Minimum of years business experience, with years in HCC or a compliance related area: monitoring, testing, auditing, finance, compliance, regulatory, law, or a related field is required. Job Title: Health Care Compliance Program Management Analyst. The Lead Analyst will provide support coordinating ...
The Main Responsibilities**+ Develop project plans to document project scope, schedule, tasks, ownership and produce status reports to communicate to team and executives+ Conduct meetings with stakeholders to determine objectives and execute on deliverables, challenges, scope, and timing; work with ...