- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …goods with Partner Government Agency (PGA) data per import scenarios, including FDA , USDA, EPA etc. + Responsible for acquiring product details from business ... SME's for HTS classification and required PGA data from Regulatory . + Assess accuracy of commercial invoice(s) to comply...of shipments held by government agencies including Customs and FDA . + Provide instructions to shippers/vendors re: BD import… more
- United Therapeutics (Trenton, NJ)
- …communications and/or commercial functions with a Master's Degree + Knowledge of compliance and regulatory framework + Exceptional soft skills including empathy ... communications, and/or commercial functions with a Master's Degree + Knowledge of compliance and regulatory framework + Exceptional soft skills including empathy… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** ... trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible… more
- System One (Park Ridge, NJ)
- …technical direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through ... advantage + Expert Microbiology and Sterilization understanding + Demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC + Strong… more
- Cardinal Health (Trenton, NJ)
- …IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory / compliance and contract manufacturing. **_Responsibilities_** + Demonstrate ... collaborate with subject matter experts from other departments, especially the Legal, Regulatory Counsel and Compliance teams + Demonstrate knowledge of general… more
- Sanofi Group (Morristown, NJ)
- …strategic business support to maintain Sanofi's commitment to ethical practices and regulatory compliance . We are an innovative global healthcare company with ... + Execute email monitoring program across multiple Business Units to ensure compliance with regulatory requirements, internal policies, and product messaging +… more
- Merck (Trenton, NJ)
- …including response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- Integra LifeSciences (Plainsboro, NJ)
- …Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements. + Participate in FDA inspections, ISO ... Quality Operations (Validations, Risk Management & Statistics)** will provide Plant Quality compliance support for the following Quality tasks and duties: Assist in… more
- Merck (Rahway, NJ)
- …Process, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems, Regulatory Compliance , Results-Oriented, Technology Transfer **Preferred ... enhance data monitoring capabilities, and drive excellence in safety, compliance , supply, and productivity. **Global Impact:** Collaborate with colleagues across… more
- Penn Medicine (Plainsboro, NJ)
- …clinical effectiveness targets and strategies annually (part of budget process). + Regulatory Compliance : Ensures all areas of accountability are compliant with ... all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA...maintain understanding and find root causes for variances Entity Compliance and Management Control - Ensure regional/practice operations fully… more