- Actalent (Basking Ridge, NJ)
- …internal procedures. The role involves coordinating labeling projects to ensure regulatory compliance and providing guidance to team members on labeling regulations ... according to internal procedures. + Coordinate labeling projects to ensure regulatory compliance. + Provide guidance on labeling regulations and process… more
- J&J Family of Companies (Raritan, NJ)
- …processes. + Plan, schedule, and coordinate project implementations to achieve regulatory and quality standards. + Develop execution plans and lead ... workshops, and meetings for continuous professional development. + Familiarity with regulatory compliance and quality standards and actively support regulatory … more
- Cardinal Health (Trenton, NJ)
- …to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company ... is seeking a driven and skilled attorney with expertise in healthcare regulatory compliance, including third party billing and reimbursement. The Assistant General… more
- Sumitomo Pharma (Trenton, NJ)
- …and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
- Cardinal Health (Trenton, NJ)
- …hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas, ... of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple functions and… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …of action and drug landscape as well as maintaining compliance in accordance with FDA , EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical ... Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve… more
- Kelly Services (Somerset, NJ)
- …quality-related software tools are effectively implemented and aligned with regulatory requirements and business needs. The engineer collaborates with ... + Ensure systems meet GMP, GLP, and other applicable regulatory standards. + Provide end-user support and training across...(eg, MasterControl), LIMS, and ERP systems. + Familiarity with FDA 21 CFR Part 11 compliance and data integrity… more
- AbbVie (Jersey City, NJ)
- …reports, assessment reports, medical safety assessments) in accordance with regulatory requirements and procedures, and in collaboration with cross- functional ... + Applies solid knowledge and understanding of applicable regulations (eg, ICH, FDA , EMA,GCP) to independently lead authoring and review of all safety deliverable… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and FDA requirements with demonstrated ability to convert complex regulatory guidelines into practical, implementable solutions + Proven expertise in Quality ... + Coordinate critical product changes, assessing 360 impacts (technical, regulatory , business) and supporting customer understanding and adoption. + Prioritize… more
- Penn Medicine (Woodbury Heights, NJ)
- … Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... items in appropriate location. + CSRs, if applicable as per regulatory guidelines: Maintains medication storage closet inventory and security; checks expiration… more