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...
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...
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...
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...
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...
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...
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 ...
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...
Cherry Hill Programs brings the magic to every experience by capturing moments that last a lifetime. In partnership with retail locations, tourist attractions, and destinations across North America, Cherry Hill Programs contributes millions of holiday and souvenir experiences for children and famili...
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...
Serve as primary regulatory liaison to commercial, medical affairs, legal, etc. Coordinate with Clinical Regulatory to plan and manage regulatory submissions related to labeling and label changes. Support budgeting and forecasting for function and Regulatory Affairs department. Minimum 10 years of r...
We are seeking an experienced and dynamic Program Manager to lead the development and execution of a global digital platform project. The ideal candidate will have a strong background in program management, excellent leadership skills, and a deep understanding of digital platforms. Program Leadershi...
Program Manager II (Commercial. Program Manager leads multiple aerospace and military engineering and manufacturing IPD teams through design, development, qualification and LRIP production phases, acting as primary point of contact for customers for these phases. Program Managers perform project pla...
The Associate Project Manager is responsible for the timely delivery of a portfolio of quality promotional medical education projects. Supporting the team on project scope, developing plans/timelines, and driving projects from inception through delivery. Adjusting schedules and targets on the projec...
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...
Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Significant experience contributing to the development of commercial regulatory or related strategies, ...
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...