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...
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...
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...
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...
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...
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...
Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function wi...
Work with Blackstone compliance regarding firm wide compliance issues and projects; and special compliance/internal audit-related projects as necessary. The CRM team is an oversight control function within BX Central Legal & Compliance designed to assess the effectiveness of BX’ policies and pro...
The Associate Director US Regulatory Affairs CMC is responsible for creation and implementation of CMC regulatory strategies to support the Bayer’s development and marketed product portfolios. Associate Director US Regulatory Affairs CMC. The primary responsibilities of this role, Associate Director...
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...
Environmental Compliance Specialist. These screenings will be conducted by Dewberry’s background vendor of choice and will be conducted in compliance with all applicable federal, state, and local law. ...
As we further expand our US presence, we have a new opportunity for a proven Project Manager to join our highly collaborative team, to oversee all commercial areas of our Audio-Visual projects and to act as the clients’ primary contact ensuring all contractual commitments are met. Oversee project In...
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, ...
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...
OVERVIEW The Affordable Program Manager, under the guidance and supervision of the Regional Director, Affordable Programing will focus on the accurate and efficient execution of and compliance with affordable housing program regulatory requirements (HUD, LIHTC, bond, and otherwise). WHY YOU’LL LOVE ...
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 ...
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 ...
The IT Compliance Analyst for our client is responsible for ensuring our compliance with Sarbanes-Oxley 404 (SOX) reporting requirements, and assisting in our other Information Technology initiatives, such as implementation of SOX framework, reviewing/validating SOC reports and assure that our syste...