Are you a passionate IT trailblazer – a growth focused, problem solver who takes full ownership of your work, wants to collaborate & co-create with fellow IT experts, innovate, learn new skills, create new solutions & drive your career to the pinnacle of your potential? If so, you will love working....
The Regulatory Compliance and Product Development Specialist ensures compliance with regulatory standards for packaging, labeling, and nutritional information, supports product development, manages costing and pricing, and collaborates cross-functionally to facilitate smooth product launches. Ensure...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
OneSource Regulatory helps companies implement the correct solutions, processes, standards, systems, templates, and best practices for effective Regulatory Operations. With the right Regulatory Operations group, our clients can achieve high quality document management, data management, and regulator...
Our Senior Regulatory Affairs Specialist position is primarily focused on maintaining continued market access of our existing product portfolio, in addition to opportunities to provide regulatory support for new product development projects. The Senior Regulatory Affairs Specialist will work in BD S...
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...
Eligibilities & qualifications....
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're seeking a detail-oriented Regulatory Specialist to ensure regulatory compliance and support product development. This role ensures packaging and labeling meet regulatory standards, supports product development, manages costing and pricing, and collaborates cross-functionally for successful pro...
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...
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...
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...
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...
Performs quality control, research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring that Good Clinical Practices (GCP) are adhered to and communicating protocol deviations appropriately per Standard Operating Procedures...
The role assists the Regulatory Manager and other associates within the Regulatory Department and works internally with Product Development, Sales/Customer Service and other internal functional areas to ensure the timely submission of the Regulatory documentation and compliance, and to support busin...
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...
Hiring - Senior Regulatory Affairs Specialist. Assess applicable change requests for regulatory impact and follow-up on related regulatory action items. Support marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing US regulatory assessme...
Autonomously support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to support the core team's approved scope of regulatory activities, with focus on instru...