- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …Quality Inspection of all incoming batches per current approved procedure + Support regulatory inspections ( FDA , DEA, VAWD/NABP, PADOH etc.) + Carry out other ... Warehouse activity will be preferred + Knowledge of GMP and regulatory requirements for the pharmaceutical industry. + Strong proficiency with applicable… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …Deviations, CAPA, Change Control related to QA and warehouse operations + Support regulatory inspections ( FDA , DEA, VAWD/NABP, PADOH etc.) + Ensure US Allentown ... Warehouse activity will be preferred + Knowledge of GMP and regulatory requirements for the pharmaceutical industry. + Strong proficiency with applicable… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …drug product. + Handling of destruction of pharmaceuticals drug products. + Support regulatory inspections ( FDA , DEA, VAWD/NABP, NJDOH etc.) + Ensure US ... Warehouse activity will be preferred + Knowledge of GMP and regulatory requirements for the pharmaceutical industry. + Strong proficiency with applicable… more
- West Pharmaceutical Services (Williamsport, PA)
- …experience working in the **medical device industry** with a strong understanding of regulatory requirements ( FDA , ISO 13485, GMP) would be an advantage. + ... Expertise in scientific molding, process validation, and statistical process control. + Knowledge of manufacturing processes, workflows, production equipment and industrial techniques. + Knowledge of Good Manufacturing Practices (GMP) requirements would be an… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …understanding of financial and business concepts. + Experience working to regulatory standards: FDA , Good Engineering Practice (GEP), Good Manufacturing ... Procedures (GMP) and Good Documentation Procedures (GDP). + Demonstrated problem solving and bias for action skill set. Demonstrated ability to define and execute a strategy while concurrently delivering to metrics and driving a culture change. + Excellent… more
- Globus Medical, Inc. (Audubon, PA)
- …their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performing… more
- Sumitomo Pharma (Harrisburg, PA)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
- Insight Global (Upper Gwynedd, PA)
- …administration, SQL, Python, web and API development with deep understanding of regulatory requirements (eg, FDA , EMA, GxP) and data governance standards. ... supporting bioanalytical assays, clinical trial data, and biomarker analysis under regulatory compliance and ensuring all data handling, storage, and processing… more