- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions,... strategy for assigned project(s). Strategize and plan for FDA meetings.Serve as the primary contact with FDA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and provide US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and ... partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... More Years in the pharmaceutical industry4 or More Years in regulatory affairs, NDA, sNDA, BLA filing to FDA Travel Ability to travel up to 30% In-house office… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for… more
- Merck & Co. (Durham, NC)
- …assay development, validation, or technical transfersPreferred:Experience with responding to regulatory questions with multiple agencies ( FDA , EMA, ... finished product, and laboratory testing for the BCG vaccine.The Senior Specialist, Quality Control participates in a team of analysts in the development,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the Quality Department in developing and ... Position Summary:The Quality Execution Counsel is a managing member of...ensuring accountability. Achieving compliance with cGMP and other relevant regulatory requirements and fostering continuous improvement are the key… more
- Aequor (Thousand Oaks, CA)
- …implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (eg FDA CFRs for Biologics and Medical Devices, ... Does the thought of building an entirely new digital quality management system, excite you? Do you love to...team? If you have a passion for streamlined, user-friendly Quality Management System enabled by digital and want to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Quality , NNI IT and Telephony, Medical Information, Compliance, Regulatory , Legal and Privacy. External relationships include Patient Support program vendors ... lead who is responsible for ensuring that all aspects of our patient quality and safety operations meets standards. This position requires a highly motivated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Quality Control Testing Scheduler as part of the Quality team based in ... organized QC Testing Scheduler to join our team for Quality Control. The ideal candidate will manage and maintain...and lab readiness are upheld for potential support of regulatory agency audits.Downtime tasks: Includes the following but not… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracks regulatory trends, legislative changes, and guidelines issued by global regulatory agencies ( FDA , EMA, MHRA, etc.) related to CSPV. Participates in ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Durham, NC)
- …development, validation, and/or technology transfer.Experience authoring technical documents supporting regulatory filings ( FDA , EMA, JNDA).Knowledge of CFR, ... active ingredient, finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the start-up… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....clinical trials In-depth knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... next generation process development and characterization, process validation, and regulatory submission authoring. In this role, the successful candidate will… more
- Merck & Co. (Rahway, NJ)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements.-This position will lead ... strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … quality practices in accordance with state and federal regulatory requirements.Strive to reduce non-conformances in supported areas by dedicatedly driving ... compliance.Ensure readiness of records for regulatory inspections and internal audits.Ability to...quality systems and SAP.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell-based products as… more
