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...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
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...
Compliance and Regulatory Specialist Location: Somerset NJ Schedule M-F 8:30 to 5:00pm On site daily Duration: 3 month contract to hire Education: * Bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assuranc...
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...
Ready to be part of something special?.This position provides technical support and guidance in FDA, USDA and CFIA label compliance regulations.This position works closely with other departments, including Legal, Marketing, Quality Assurance and Operations and will work with outside consultants as n...
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...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
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...
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. ...
Define, implement, and improve the Quality Management System with guidance from the site Quality Manager including development of process and product testing to ensure quality standards are met and oversee determination of finished product disposition. Implement, maintain, and audit quality control ...
A client of Innova Solutions is immediately hiring for Project Manager-Power Transmission and Distribution. ...
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...
Financial management and reporting for the IT programs/projects. Excellent in project/program status and governance reporting. Program/Project Management (Preferably for Financial clients). ...
Regulatory Affairs Manager (Parsippany, NJ) to write, review and compile documentation and data necessary for the following: submissions of assigned ANDAs, responses to FDA Deficiency letters, Correspondences and post approval supplements to ensure compliance with applicable regulations and guidance...
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 se...
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 se...
Develop Regulatory Strategy for assigned projects by designing and assessing regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory Plan). DVM or Pharm D with 6 years of experience in medical research activities of which 1-3 years should include local/global...
The purpose of the position is to identify and resolve compliance and eligibility issues with contracted managed care customers. This position works with the Teva Market Access account managers and the contracted account to gain alignment on formulary product placement and compliance and to recover ...
Project Manager with experience to join our expanding team. Excelling in all phases of construction for sewers, water/wastewater, Pump Stations and site development projects. Water and wastewater design projects experience. Pump station design and rehabilitation, collection system condition assessme...
Must have 10 years of overall experience with career track going from Engineering background in Mobile App Development to Program Manager . Translate the components, dependencies and work breakdown into a program schedule. Manages the program schedule to meet on budget and on time delivery through 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 ...
The Manager of Regulatory Affairs will lead the regulatory strategy and submission processes for Chemistry, Manufacturing, and Controls (CMC) associated with Abbreviated New Drug Applications (ANDAs) and generic products. Minimum 5 years of experience in regulatory affairs within the pharmaceutical ...
This position will require the skillset of an experienced project manager who has successfully delivered large scale, multi-phased system implementations with multiple work streams, numerous different types of stakeholders and the ability to comfortably deliver updates and relay information to vendo...