- Teva Pharmaceuticals (Parsippany, NJ)
- …detail aid, slide decks, websites, patient materials, etc.) meet the US Food and Drug Administration ( FDA ) Code of Regulations and guidance documents, as well as ... and work closely with key members of internal departments including, Legal, Regulatory Affairs, Marketing, Global Health Economics, Value and Outcomes (Global HEVO),… more
- Integra LifeSciences (Plainsboro, NJ)
- …a thorough understanding of the following regulations and guidelines: US Food and Drug Administration ( FDA ) regulations, ISO 9001, ISO 13485:2003, Medical Device ... Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements. + Participate in FDA inspections, ISO… more
- Taiho Oncology (Princeton, NJ)
- …and/or leading a cross-functional team. + Expert knowledge of relevant food and drug administration ( FDA ), European union (EU) and international conference on ... of our team, you'll have the opportunity to shape the future of drug safety, contribute to groundbreaking research, and advance patient care worldwide. With… more
- Norstella (Trenton, NJ)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... clients navigate the complexities at each step of the drug development life cycle -and get the right treatments...structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in… more
- Bristol Myers Squibb (Princeton, NJ)
- …pharmaceutical (medical device, biologics) facilities and have worked for the US Food & Drug Administration ( FDA ), within the past 10 years (2015-2025) in a ... a risk-based approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …GxP compliance, Ethics & Compliance, and Pharmacovigilance, ensuring alignment with regulatory requirements and business objectives. This strategic leader will be ... engaging training ecosystem that enhances employee learning experiences and supports regulatory compliance. + Oversee the development and global deployment of… more
- Merck (Rahway, NJ)
- …our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms. ... actions. **Preferred Experience and Skills** : + Familiarity with regulatory requirements and Good Documentation Practices (GDP). + Experience with… 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...stakeholders to ensure consistent, accurate communication of medical and drug information and Leads cross-functional and/or global initiatives in… more
- Stryker (Mahwah, NJ)
- …in CAD software (SolidWorks, Creo) + Familiarity with validation protocols and regulatory compliance ( FDA , ISO 13485). Health benefits include: Medical and ... + Execute IQ/OQ/PQ validation protocols to ensure compliance with FDA and ISO 13485 standards. + Establish robust process...production risks. + Maintain DHF and DMR documentation for regulatory compliance. + Drive Lean and Six Sigma initiatives… 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