- Mondelez International (East Hanover, NJ)
- …are achieved with high quality results and alignment with Legal, Quality , Category managers and Regulatory leads. **Education / Certifications:** Master's ... Rights: Workplace Discrimination is Illegal **Job Type** Regular Scientific Affairs & Regulatory Affairs Product Quality , Safety and Compliance At Mondelēz… more
- Sanofi Group (Morristown, NJ)
- …communicated, and mitigated as necessary. + Oversees strategic negotiations with worldwide Regulatory Agencies, including directly with FDA and EMA, so that ... **Job Title:** Head of Global Regulatory Affairs, CMC Small Molecule **Location:** Morristown, NJ...secure timely approvals while maintaining the highest standards of quality and compliance, ultimately supporting Sanofi's goal of bringing… more
- Parexel (Trenton, NJ)
- …and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master ... shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront...activities as well as facilitate business decisions + Produces quality work that meets the expectations of RS and… more
- Parexel (Trenton, NJ)
- …the world, ensuring innovative products are supported by clear, compliant, and high- quality documentation that enables safe and effective use across global markets? ... Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for complex… more
- J&J Family of Companies (Titusville, NJ)
- …impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job ... Johnson Innovative Medicine R&D is recruiting for a Manager, Regulatory Scientist. This position is a hybrid role and...for respective/regions and countries ensuring they are of high quality and submitted in accordance with timelines. + May… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and Skills** + Comprehensive understanding of medical device regulations, standards, and the regulatory submission landscape (eg FDA , EU MDR, EU IVDR, ISO) + ... us. **Job Overview** Working closely with the Director of Regulatory Affairs, the Regulatory Affairs Manager -...in a cross functional team environment. + Knowledge of quality management systems and risk management principles. At BD,… more
- Sumitomo Pharma (Trenton, NJ)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/She...provides possible solutions and mitigation strategy + Ensures the quality and content of all submissions to Health Authorities… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... be critical in helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with other key functional… more
- System One (East Windsor, NJ)
- Job Title: Quality Compliance Associate Location: East Windsor, New Jersey Type: Contract Compensation: $26 - $36 per hour Contractor Work Model: Onsite Hours: 8/9 ... + Under the oversight of the Associate Manager of Quality Assurance (QA) Compliance, this position will be responsible...system to notify the US Food and Drug Administration ( FDA ) of illegitimate products, as and when needed. +… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, ... in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key… more