- Novo Nordisk Inc. (Plainsboro, NJ)
- …in compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains proficient understanding ... provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews systems and procedures.Ensure trending… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... thereby ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation… more
- Lundbeck (Fort Wayne, IN)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... of the value chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to… more
- Lundbeck (Waco, TX)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical and regulatory environment,… more
- Lundbeck (Joliet, IL)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit ... provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of PV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA , EMA) (Required)2 or more years ... areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… more
- Repligen (Waltham, MA)
- …growing Supplier Quality team. You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This is an opportunity to ... based in Waltham, MA, and will report to the Senior Manager of Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze, and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …activities Ensures change control activities for systems are completed in a manner in compliance with FDA , EU and NN regulations Responsible for the verification ... candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with coordinating… more
- Eisai, Inc (Nutley, NJ)
- …speaker programs for meaningfulness, effectiveness, educational in nature, and compliance with company policies. Essential Functions KOL Engagement Engage with ... the patient journeyIdentify and ensure training (product, disease state and compliance training) for promotional speakers and related aspects of speaker… more
- Danaher Corporation (Austin, TX)
- …(https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Manager , Clinical Quality and Compliance reporting ... and program including internal GCP auditing (ie, TMF, SOP compliance , training, etc.), interface to the FDA ...SOP compliance , training, etc.), interface to the FDA and notified bodies, clinical CAPA management, and IVDR… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Manager , Field Alert & Recall Compliance is responsible for overseeing regulatory activities related to Field Alert Reports (FARs), product ... recalls, and market withdrawals, including investigation management, FDA notification, and effectiveness monitoring. This role leads site-wide and cross-departmental… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- Quality Compliance Manager Department: Quality Location: Allentown, PA START YOUR APPLICATION ... (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3446854&source=3446854-CJB-0) About the Job The Quality Compliance Manager is responsible for overall … more
- Teva Pharmaceuticals (North Wales, PA)
- Manager , US Customs & Trade Compliance Date:...US Customs & Trade Compliance (CTC)will ensure compliance with Customs, FDA , USDA and other applicable ... focus is both import and export compliance * Ensure compliance with Customs, FDA , USDA and all other government agencies * Monitor, research and respond… more
- Takeda Pharmaceuticals (Boston, MA)
- …be a necessary contributor to our inspiring, bold mission. **_GOALS:_** The Global Trade Compliance Manager will ensure that Clinical and R&D imports and exports ... and empower you to shine? Join us as a Manager , Global Trade Compliance based in Cambridge/Lexington,...Regulations. This includes US Customs and Border Protection, USDA, FDA , Fish Wildlife, Public Health, Bureau of Industry and… more
- Abbott (Alameda, CA)
- …levels with our new sensing technology. **The Opportunity** This **Regulatory Affairs Manager - International Compliance Operations** will work on-site at our ... their glucose levels with our new sensing technology. This **Regulatory Affairs Manager - International Compliance Operations** will provide support for the… more
