- Burlington (Burlington, NJ)
- **LOCATION** 1830 Route 130 North Burlington NJ US 08016 **Overview** The ** Product Safety & Regulatory Compliance Manager** will play an integral role ... in supporting Burlington's Product Safety & Regulatory Compliance Center of Excellence. The Manager will engage with cross-functional partners, third… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …years regulatory and/or related experience. + Knowledge of US and EU product labeling regulatory requirements and guidelines. + Familiarity with US and/or EU ... for the development and implementation of labeling content and strategy of assigned product (s) in various stages of drug development, which may include products of… more
- Merck (Upper Gwynedd, PA)
- …+ Establishing an effective implementation and oversight model to maintain best-in-industry regulatory compliance . The Vice President Regulatory Affairs, ... contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function...in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.… more
- Merck (West Point, PA)
- …fabrication, FAT, SAT, Validation etc.) + Experience in regulatory compliance expectations across all phases of product development to commercialization. ... Duties & Responsibilities for the Director Include:** + Sterile drug product development concepts, tools, and technical/ operational/ regulatory requirements… more
- J&J Family of Companies (Horsham, PA)
- …direction for refining policies and procedures for maintaining and enhancing medical safety compliance and operational excellence with goal of continuous ... risks, to Senior Management, HAs, Prescribers and/or Patients. In compliance with legal and regulatory requirements, the...**Travel** Yes, 10 % of the Time **Job Function** Product Safety Risk Management MD **Req ID:**… more
- Food Safety and Inspection Service (Pedricktown, NJ)
- …safe product by executing appropriate inspection methods, determining non- compliance with regulatory requirements, documenting noncompliance and initiating ... records, observe plant operations and conduct hands-on verification to ensure compliance with regulatory requirements and prepare detailed documentation (Non-… more
- Organon & Co. (Plymouth Meeting, PA)
- …liaison with Organon sites worldwide for complaint-handling activities to assure regulatory compliance is maintained. Provides expertise on processes and ... Quality Complaint (PQC)/Adverse Event (AE) management processes are in compliance with global regulatory expectations. Responsible for global complaint… more
- J&J Family of Companies (Spring House, PA)
- …service providers and solution vendors to ensure delivery of solutions. + Ensure compliance with all relevant regulatory standards and ethical guidelines when ... Director- Product Group Leader - 2406189854W **Description** Johnson &...required in the pharmaceutical development IT (Clinical, Pharmacovigilance, and Regulatory ) preferably focused on Clinical. + Proven hands-on experience… more
- Zurich NA (Trenton, NJ)
- …forms and approaches to coverage in new products + Participate in compliance -related queries, including state regulatory exams and insurance department inquiries ... review and approval process + Analyzes and develops solutions pertaining to Insurance Regulatory requirements with respect to product filings within scope of… more
- Veolia North America (Philadelphia, PA)
- …and process trending. + Consistently demonstrate compliance with regulatory requirements, company policies, and Safety rules/procedures. + Maintain ... strong professional relationships with Manufacturing, Sourcing, Regulatory , Technology, EHS, + Product Management and Commercial teams. **Qualifications**… more
- Greene Tweed (Kulpsville, PA)
- …include interpreting product or contractual requirements, ensuring documents meet compliance and regulatory standards, and may prepare process documents, ... intra lab alignment. . Schedule and monitor internal audits. . Support Material Compliance and GT's regulatory status through maintenance of our chemical… more
- Schwan's Company (Robbinsville, NJ)
- …transactions in SAP to release product from QA hold + Verifies regulatory formula and procedural compliance of manufacturing systems and takes corrective ... when necessary + Documents review and verification to ensure compliance to company and regulatory requirements +...Complete the investigation and the documenting of incidents involving product /ingredient Food Safety issues + The use… more
- J&J Family of Companies (Horsham, PA)
- …Johnson products and will strategically lead cross-functional matrix teams responsible for product safety and benefit risk oversight and represents Global ... Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the...**Travel** Yes, 10 % of the Time **Job Function** Product Safety Risk Management MD **Req ID:**… more
- J&J Family of Companies (Horsham, PA)
- …Johnson products and will strategically lead cross-functional matrix teams responsible for product safety and benefit risk oversight and represents Global ... Senior Management, Health Authorities (HA), prescribers and/or patients. In compliance with legal and regulatory requirements, the...**Travel** Yes, 10 % of the Time **Job Function** Product Safety Risk Management MD **Req ID:**… more
- IFF (Wilmington, DE)
- …assessments). + Experience successfully impacting product introductions by providing regulatory & safety guidance and/or successfully influenced decisions to ... interpret US and Canadian regulations; draft submissions/documentation to support product safety for US (eg, GRAS) and...and Cultures, and Grains Processing + Contribute to global regulatory compliance programs for IFF marketed products… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …and/or update product labeling (ie CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and ... of drug development, which may include one high complexity product and updates to or creation of a new...executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority… more
- Pfizer (Collegeville, PA)
- …assistance to new business development on market opportunities and the target product profile. **ROLE RESPONSIBILITIES** **Accountable for safety across the ... during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial,...and any significant new adverse events. + Monitor investigator compliance with protocol and regulatory requirements. +… more
- Penn Medicine (Philadelphia, PA)
- …effective and efficient organizational design including innovative care team models. Regulatory Compliance : (In partnership with CPUP, SOM, and University) ... to stay competitive and innovative for patient needs. DOO ensures compliance with regulatory bodies. **Responsibilities:** Department Strategic Planning &… more
- J&J Family of Companies (Trenton, NJ)
- …responsible for: * Train, coach and mentor Abiomed teams in the execution of the Product Issue Escalation process to ensure compliance with MD and J&J standards. ... to execute root cause investigation and bounding, to assess regulatory and medical safety impact and review...as early as possible, communicate to management on high-risk safety , quality or compliance issues * Lead… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …material management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA ... a Patient First culture through excellence in quality and compliance , and to the safety of every...+ Anticipates internal and or external business challenges and/or regulatory Issues; recommends process, product or service… more