- Genmab (Morrisville, PA)
- …our best, and authentic is essential to fulfilling our purpose. Associate Digital Product Manager, Global Drug Safety and Pharmacovigilance This person will be ... product owner, product manager, senior business analyst in Global Drug Safety and Pharmacovigilance areas, with at least 3 years in a delivery leadership… more
- Genmab (Yardley, PA)
- …proactively and in response to requests for information, consistent with promotional compliance and regulatory requirements Develops and maintains a network of ... will be a key member of the USMA leadership team, contributing to product launches & development efforts, responsible for shaping team culture & employee… more
- 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
- The Boeing Company (Ridley Park, PA)
- …training criteria and certification duration in order to ensure personnel safety , product integrity, and/or regulatory compliance + Assists in the ... exams and maintaining records to ensure NDE personnel meet job qualifications and regulatory compliance + Achieves NDE Level III certification in the appropriate… 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
- Cline Davis & Mann (Doylestown, PA)
- …Shop **Background on Compliance -** In order to comply with global safety regulations, pharmaceutical companies are required by law to collect and evaluate all ... market research, Adelphi operates in a demanding and ever-changing compliance environment. **Title** :Global Adverse Event and Compliance...adverse events and product complaints associated with their products. Currently, The Planning… more
- Merck (West Point, PA)
- …all functions of our company while driving improvements and alignment for regulatory compliance worldwide. **Responsibilities:** + Manage and provide leadership ... **Job Description** **Position Description:** **Director, Product Stewardship** Our Global Safety &...the company's strategic direction on future-driven initiatives related to Product Stewardship and compliance . + Oversee the… more
- Food Safety and Inspection Service (Norma, 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
- Sumitomo Pharma (Trenton, NJ)
- …+ Responsible for implementation and maintenance of serialization systems to ensure compliance with regulatory requirements and enhance traceability within the ... employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules… 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
- 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
- J&J Family of Companies (Horsham, PA)
- …preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety -related decisions for ... and products in development. The AD SAS will support product Safety Management Teams (SMTs) and work...revisions required. * Provide input and review of key regulatory or clinical documents as appropriate. * Demonstrate leadership… more
- Barry Callebaut (Eddystone, PA)
- …good GMP's + Committed to providing a safe food product + Works within all regulatory requirements + Safety supervisor + Safety Talks and reporting of ... Supervisor, Inventory/ Safety Location: Eddystone, PA, US, PA 19022 At...sector, from the cocoa bean to the finest chocolate product . We are a company with a purpose, we… 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
