- AUROBINDO (Durham, NC)
- …the accuracy of analytical measurements and compliance with cGMP, US FDA , and other regulatory and corporate requirements.Conducting troubleshooting and ... and validation, with prior supervisory roles being advantageous.Familiarity with pharmaceutical regulatory standards, including USP/ICH/ FDA 21 CFR 210/211, CFR… more
- Repligen (Waltham, MA)
- …as neededMaintains regulatory compliance through continuous monitoring of International regulatory standards (eg WHO, EMA, FDA , ISO)Develops & maintains ... OverviewThe Senior Director, Global Regulatory Affairs will report directly to the VP,...VP, Global Quality.This role will be accountable for the Regulatory oversight of all Repligen products and will be… 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 ... directly to the Vice President, CMR Strategic Operations. External relationships include regulatory authorities: FDA and MDR and relevant vendors. Internal… more
- Formation Bio (New York, NY)
- …and Business Development teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities. ... Represent Biostatistics in key regulatory meetings (eg, FDA , EMA) to ensure statistical rigor in clinical development plans. Operational Excellence: Establish… more
- Tris Pharma (Monmouth Junction, NJ)
- …to strategy discussions in cross functional settingsExperience interacting with the FDA and other regulatory organizationsHands-on experience with statistical ... accuracy and integrity, contributing to research protocol development and supporting regulatory submissions. Provides expert statistical input in design and analysis… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- 7 or more years training and compliance background and strong knowledge of FDA and EU regulatory requirements, industry audit processes, and Data Management ... quality delivery of data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for ensuring all… more
- Butterball (Clinton, NC)
- …practices are completed and documented appropriately. Ensures compliance with all FDA and regulatory requirements, including necessary documentation.4. Partners ... the feed production process* Firm understanding of safety and regulatory compliance standards in manufacturing* Administrative experience within logistics and/or… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the following is desired: Microsoft Windows Operating Systems and Networking systems (Ethernet) FDA and EMEA Regulatory requirements Experience at a medium to ... (5) year of direct engineering Pharmaceutical, Biotechnology or other regulatory industries experience preferred Knowledge, Skills, and Abilities: Strong knowledge… more
- Merck & Co. (Rahway, NJ)
- …phase drug product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA , ICH, ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …additional years of relevant experience Deep understanding of drug development processes, regulatory requirements ( FDA , EMA), and clinical trial design across ... opportunities. Evaluate the strength of clinical data, safety profiles, regulatory pathways, and competitive positioning. Portfolio Alignment: Ensure new business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible ... for the training of Manufacturing Excellence on MES utilization and ensuring that Manufacturing Excellence properly assesses updates and impact.Key Relationships: establish key stakeholder relationships with internal and external stakeholders. Ability to… more
- Formation Bio (New York, NY)
- …maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA , EMA), industry standards (eg, cGMP), and ... and educate stakeholders at all levels of the organization. Experience leading regulatory inspections (eg, FDA inspections, MHRA inspections, EMA inspections,… more
- Formation Bio (New York, NY)
- …and/or pharmacovigilance documents are developed in a format compliant with the governing regulatory agency (EMA, FDA , and ICH guidelines) and with electronic ... managing other writers (internal or contract) preferred. Understanding of FDA /international regulations, ICH guidelines, and applicable US/international regulatory… more
- Formation Bio (New York, NY)
- …that all clinical trials are conducted in accordance with ICH-GCP guidelines, FDA regulations, and other applicable regulatory requirements. Ensure that clinical ... that trials are executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial Managers (CTMs)… 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 ... provide US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to… more
- Formation Bio (New York, NY)
- …and educate stakeholders at all levels of the organization. Experience leading regulatory inspections (eg, FDA inspections, MHRA inspections, EMA inspections, ... perform batch record reviews to ensure accuracy, completeness, and compliance with regulatory requirements. Manage QA release of clinical trial materials to ensure… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA , GLP, QSR, cGMP, USP, and CDR ... and troubleshoot procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and combination drug manufacturing labs.Help… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive ... and clinical studies. Collaborate with cross-functional teams (Clinical Development, Regulatory , Program Management, etc.) to shape and refine Strategic Development… more
- Merck & Co. (Rahway, NJ)
- …GLP.Thorough understanding of clinical research and clinical trial methodologies.Strong regulatory knowledge, including FDA /CVM, EMA/CVMP, and VICH ... stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA , EMEA).Responsible to maintain permanent inspection ... with all operations work-cells to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes.Serves as Subject… more
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