- Heritage Pharma Labs Inc.d/b/a Avet Pharmaceuticals Inc. (East Brunswick, NJ)
- …Knowledge: + Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements (cGMP, FDA guidelines). + Knowledge of Utility ... and a deep knowledge of pharmaceutical manufacturing processes and regulatory requirements. The Maintenance Engineer collaborates with cross-functional teams to… more
- Honeywell (Hamilton, NJ)
- …with digital transformation initiatives in pharma or biotech. + Familiarity with global regulatory frameworks (eg, FDA , EMA, ISO). + Exposure to AI/ML, data ... value propositions tailored to life sciences personas. + Align messaging with regulatory , operational, and innovation drivers in manufacturing and quality. + Partner… more
- Cytel (Trenton, NJ)
- …with a strong foundation in statistics. + Demonstrated experience interacting with regulatory agencies (eg, FDA , EMA) and contributing to health authority ... machine learning), with experience across all phases of development and global regulatory interactions. We are seeking an **Executive Consultant** - a seasoned… more
- Novo Nordisk (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Nordisk products and in compliance with Novo Nordisk and FDA requirements + Responsible for Product Safety compliance across… more
- Oracle (Trenton, NJ)
- …**Oracle Cloud SCM, Manufacturing, Quality, and ERP** integrations. + Knowledge of ** regulatory compliance processes** ( FDA , ISO, cGMP) and quality documentation ... management. + Familiarity with **Oracle Visual Builder Studio** , **BI Publisher** , and **Reports** for PLM analytics. + Certification in **Oracle Cloud PLM or PDH** modules. + Strong understanding of **product data governance frameworks** and enterprise data… more
- Hovione (East Windsor, NJ)
- …and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines ... and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications. - In the early… more
- ConvaTec (NJ)
- …Under Bond (TIB) process for goods entering the country for temporary purposes ensuring regulatory adherence. + Manage the FDA Import for Export (IFE) program ... and experience working in customs programs globally eg Import for Export ( FDA ), Temporary Imports, Free Trade Agreements, Preferential Origin. + Experience working… more
- Wolters Kluwer (Princeton, NJ)
- …engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. ... managing the software development plan and partnering with engineering, quality, and regulatory team members to aligning the process with agile and lean engineering… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Experience with state and federal health care programs, fraud and abuse laws, FDA , FTC, and the legislative and regulatory process. + Familiarity with ... Policy teams and senior management on complex policy issues, statutory and regulatory interpretation, and legal strategies to protect the Company's interests. The… more
- ManpowerGroup (Wayne, NJ)
- …+ Excellent communication skills for documenting and collaborating with teams. + Knowledge of regulatory standards such as FDA 21 CFR Part 820 and ISO 13485 ... clearly and accurately in complaint records, ensuring compliance with regulatory standards. + Collaborate with cross-functional teams including R&D, Manufacturing,… more