- Bayer (NJ)
- …timely and accurate implementation of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling ... of and adherence to US regulations, especially as they apply to compliance , to support labeling-related regulatory activities. Scientific and technical expertise… more
- Bristol Myers Squibb (Princeton, NJ)
- …risk management and compliance with local and international PV regulations (eg, FDA , EMA, ICH). + Oversee safety operations team members and vendors in managing ... key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards, and drives the strategy and execution… more
- CSL Plasma (Clifton, NJ)
- …role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and ... facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for deficiencies.… more
- Mondelez International (East Hanover, NJ)
- …audits across various departments and functions within the organization to assess compliance with quality management systems and regulatory standards. + Involves ... company's products meet the highest standards of quality and compliance . **What extra ingredients you will bring:** + Develop...to internal quality standards (eg, OQS, SQE) and external regulatory requirements (eg, FDA ). + Review corrective… more
- Sysco (Rahway, NJ)
- …Quality Management System (QMS) that ensures product excellence, customer satisfaction, regulatory compliance , and business continuity across the entire supply ... improvement of an integrated QMS that meets ISO 22716 (Cosmetic GMP), FDA , EPA, and international regulatory standards. + Govern documentation systems,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance , R&D quality and fit-for-purpose to both Gilead business needs ... oversight and completion of assigned tasks. + Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …product ideation, concept development, product verification, and validation, legal and regulatory compliance , demonstration of product value, and stakeholder ... performance of all products. Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world as needed +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …oversight and completion of assigned tasks. + Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables. ... and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements. +...the drug development process and GVP, including global regulations ( FDA , EMA, ICH) and their application to cross-functional drug… more
- Actalent (Princeton, NJ)
- …and management of clinical trials across multiple phases. This role ensures compliance with regulatory requirements, timelines, and budget constraints while ... maintain detailed project plans, timelines, and budgets. + Collaborate with regulatory teams for submissions, amendments, and compliance -related documentation. +… more
- Integra LifeSciences (Princeton, NJ)
- …endotoxin-related risks from both a product and patient safety perspective. ** Regulatory Compliance & Documentation:** + Ensure thorough documentation and ... + Detail-oriented with a commitment to maintaining high-quality standards and regulatory compliance . + Experience with quality management systems (QMS)… more