The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Compliance Group. The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry and their impact on manufacturin...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
Provide consultation and advice to regulatory specialists regarding change control and product development. Offer regulatory direction and interpretation on team activities. Apply regulatory knowledge to support product-related activities. Prepare regulatory submissions and registration documents fo...
We are seeking a highly skilled BCBA QA Specialist with experience in the. Review ABA treatment plans for clinical and insurance compliance. Ensure proper authorization approvals and compliance with audits. Proven experience as a QA specialist in the ABA field. ...
Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. Can serve as Quality Assurance representative on facility projects. Minimum of 2 years in a Quality Assurance role. This experience should be in the areas of the Quality System that inc...
Due to expansion, our multi-discipline firm is seeking a full-time Senior Project Manager. Our project portfolio includes private, municipal, county, and regional clients; some have been with our firm for three decades. Oversee the development of scopes of work, budgets, plans, as well as the execut...
Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities . Those aren’t words that are usually associated with a job. Develop global and/or US regulatory strategy for Oncology products in development and through life cycle management, ...
Reporting directly to the Chief Scientific Officer, the Head of Regulatory Affairs will manage the regulatory team and work closely with R&D, Technical Operations, Clinical Development, and external consultants. Minimum of 10-15 years of experience in regulatory affairs within the pharmaceutical or ...
You will manage approximately multiple projects at any given time (dependent on project scope and complexity) and will participate in oversight of contractors, construction schedules, and providing status reports and communication to internal and external project stakeholders. Manages and executes d...
We are hiring for a Sr Project Manager with a background in OTC. They will also effectively monitor and present project updates to relevant stakeholders, clients, or project team members. The ideal candidate will be responsible for planning, coordinating, and implementing projects within the decided...
Responsible for assisting the Regulatory Team with the processes of maintenance and registration of new products and state wholesaler licenses as required from the FDA (Food and Drug Administration) and other regulatory agencies. At least 5 years of experience in the pharmaceutical industry includin...
The scope of this position is engineering work, including all aspects of Facilities Project Design and managing, monitoring, and controlling projects to ensure that they safely achieve the Project deliverables within the approved scope, cost and schedule. Strong project management skills are require...
The Vocational Services Program Manager is instrumental in leading a team dedicated to providing comprehensive training programs designed to help individuals with disabilities develop essential job skills. Vocational Services Program Manager. Design and execute innovative programs and strategies to ...
As the Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. The Director will also ser...
Work with Senior Project Managers. Must have Data Management Project Management experience. Need 4+ years of Project Management experience. ...
On-Board Scientific is hiring a Regulatory Affairs Assistant!. The Regulatory Assistant needs to exhibit working knowledge of pharmaceutical operations. The Regulatory Assistant will need to utilize scientific and technical information to ensure that documents produced are consistently accurate and ...
You'll be a member of the Content and Policy Analyst that define content standards and outline policy and inclusion criteria for our FCC and Trade Compliance business. You will support the management of our World Compliance data, specifically the maintenance and dissemination of our researcher-facin...
Management experience with at least one transportation project with major ITS work or served as Deputy Project Manager for two transportation projects with major ITS work from concept development (CD) through PS&E phase. In this Senior PM role, you will apply technical expertise and project manageme...
Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, and competitor analyses) for Target Product Labeling, CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentraliz...
Manage the budget and schedule for the projects assigned,Responsible for managing multiple assigned on boarding projects to completion,Coordinating interrelated operational tasks required to support the proposed solution (2. ...
The Pharmacy Program Manager position is a 100% remote role requiring a HIPAA-compliant workspace. A Pharmacy Program Manager is a Clinical Pharmacist providing pharmacist support for an interdisciplinary care management team and members under assigned plan sponsors through conducting comprehensive ...
Identify and flag potential risks and issues that may impact project timelines or quality, develop mitigation strategies or contingency plans to address risks and provide regular project updates to key stakeholders. The successful candidate will be responsible for leading Appian development projects...