- Canon USA & Affiliates (Trenton, NJ)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is ... of reportable events + Provide information as requested for the filing of FDA recalls + Coordinate FMI process, including monitoring and reporting status and… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …strategic regulatory advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory impact of changes ... Description: Regulatory expert in the area of Biosimilar/BLA submissions...of Biosimilar/BLA submissions including strategize, compile, review and manage/lead regulatory submissions. Subject matter expert in the area of… more
- Nestle (Bridgewater, NJ)
- …of health and nutrition for patients and consumers. **Position Summary:** The Regulatory & Scientific Affairs Senior Manager is responsible for assuring that Nestle ... Nestle policies. This function is responsible for but not limited to regulatory compliance as pertains to ingredient and product composition, labeling, product… more
- Merck (Rahway, NJ)
- …Director, Portfolio & Program Management (PPM)** The Associate Director in Regulatory Planning and Publishing works closely with various stakeholders to drive ... execution, and management of activities that deliver high quality and timely regulatory and safety submissions for approval. The incumbent will be responsible for… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- Integra LifeSciences (Plainsboro, NJ)
- …patient outcomes and set new standards of care. The **Internal Auditor, Regulatory Compliance** will have an in-depth understanding and knowledge of appropriate GMP ... on-going project support and governance, as assigned. + Provide support for regulatory inspections, input to responses and corrective action plans and ensure the… more
- Sokol Materials & Services (Skillman, NJ)
- …principles and methodologies, including risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. ... plans, test protocols, summary reports, and traceability matrices, ensuring regulatory compliance and accuracy. * Investigate and resolve deviations encountered… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …comparator drugs and other co-meds for clinical studies . Mature knowledge of the FDA , cGMP, GCP standards and regulatory guidance documents such as CFR, Annex ... Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the ... In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and… more
- Honeywell (Hamilton, NJ)
- …transfer streamlining, batch execution and recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), manufacturing analytics, digital ... critical challenges including technology transfer, batch execution, quality management, regulatory compliance, and operational efficiency. **Key Responsibilities** Lead and… more