- Sumitomo Pharma (Trenton, NJ)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... protocols. + Oversee clinical trial execution, ensuring quality, patient safety, and compliance with GCP standards. + Develop and execute corporate clinical strategy… more
- System One (Florham Park, NJ)
- …in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission Gateways (ESG), as well as, prepare ... and file non-eCTD submissions to ensure compliance with applicable laws and regulations. This includes publishing...submission documents. + Familiar with regulatory guidelines, such as FDA , EMA, MHRA, and Health Canada. Knowledge and understanding… more
- ManpowerGroup (Wayne, NJ)
- …Development and Engineering team. This critical role ensures the quality and compliance of medical devices throughout the product development lifecycle. You will ... teams to identify risks, implement quality controls, and ensure compliance with industry regulations and standards. **What You'll Be...follow Design Control procedures and regulatory standards (ISO 13485, FDA 21 CFR Part 820, EU MDD, EU MDR).… more
- Actalent (Princeton, NJ)
- …management of clinical trials across multiple phases. This role ensures compliance with regulatory requirements, timelines, and budget constraints while driving ... + Collaborate with regulatory teams for submissions, amendments, and compliance -related documentation. + Address protocol deviations, audit findings, and inspection… more
- Lilly (Branchburg, NJ)
- …to organizational transformation and data analytics. + Ensure MES system is in compliance with industry-specific regulations, such as FDA guidelines and GMP ... processes and procedures are in place for all activities to meet quality and compliance standards. Experience with GMP regulations. + Must assist with the support of… more
- Actalent (Basking Ridge, NJ)
- …This position requires reviewing label content to ensure accuracy, consistency, and compliance . The role involves using labeling software to prepare and submit SPL, ... to labeling updates. + Coordinate labeling projects to ensure regulatory compliance . + Facilitate project completion through effective and detailed project… more
- Kedplasma (Cinnaminson, NJ)
- …Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... product quality, and ensuring product quality. . Ensures production personnel follow compliance of all Center activities with cGMP, KEDPLASMA DCOP's and other… more
- Merck (Trenton, NJ)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this position ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- Kelly Services (Bridgewater, NJ)
- …strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies. + Monitors FDA ... and advertising strategies. + Provide regulatory support as needed for FDA warning and untitled letters, FTC letters, and direct competitor-to-competitor challenges… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …goods with Partner Government Agency (PGA) data per import scenarios, including FDA , USDA, EPA etc. + Responsible for acquiring product details from business ... of shipments held by government agencies including Customs and FDA . + Provide instructions to shippers/vendors re: BD import...Centers and others to ensure that all import trade compliance requirements are met. + Identify standard import process… more