- 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 ... well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From healthcare 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...compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From healthcare 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...highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Lundbeck (Fort Wayne, IN)
- … regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability ... the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From healthcare 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...chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Lundbeck (Waco, TX)
- …issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical and regulatory ... 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… 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 ... Companion Diagnostic products preferredProven experience with Health Authority Inspections, (eg, FDA , HPFB, MHRA and other European regulatory agencies)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety...management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… 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
- Bausch Health (Bothell, WA)
- …guidance, and national/international standards. Work together with Bausch Health Group PRC regulatory lead, ensuring regulatory compliance for Solta ... Manager , Regulatory Affairs Medical Device-Aesthetics (Bothell,...requirements, as well as leadership and guidance on global regulatory strategy, such as US FDA product… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- …on frequent interactions with technical teams Review technical documentation to ensure regulatory compliance and conformance with existing regulatory ... Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant...degree (PharmD or PhD), plus 3 years of hands-on regulatory experience, Knowledgeable in ICH and FDA … more
- Medline (Winnetka, IL)
- …to people, process, and systems improvement. The position reports to a Global Trade Compliance manager and collaborates with other Global Trade Compliance ... compliance that arise Collaborate with business units to proactively identify compliance issues and comply with regulatory obligations Responsible for… more
- Kaiser Permanente (Oakland, CA)
- …data management, Institutional Review Board (IRB) practices, and export controls. The manager will oversee compliance with regulatory requirements and ... Senior Manager , Research Compliance The Research Compliance Manager...Compliance ) is needed for this position Familiarity with regulatory agencies and bodies (OHRP, ORI, FDA ).… more
- Phoenix Closures, Inc (Aurora, IL)
- …Regulatory Affairs Manager to assist with all matters pertaining to regulatory affairs and compliance with internal and external policies and standards. ... standards and regulations. This position, as directed by the Regulatory Affairs Manager , will assist with reviewing...ERP system. Assist in entering new and reviewing existing regulatory / compliance information for raw materials in the… more
- Abbott (Pleasanton, CA)
- …results. Analyze trends from various sources and proactively address regulatory , compliance , and quality issues. Actively participate in FDA inspections and ... get on with their lives. As a Senior Quality Compliance Manager , the individual will play a...work environment. Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies,… more
- Invivyd (New Haven, CT)
- …In March 2024, Invivyd received emergency use authorization (EUA) from the US FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. ... of making a difference. Be part of Invivyd. Job Title: Senior Manager /Associate Director, Drug Safety and Pharmacovigilance Operations Position summary: The Sr. … more
- Abbott (Buffalo Grove, IL)
- …quality related crises. Quality Management System (QMS) responsibility for TPM ensuring robust compliance and alignment with FDA , ISO, cGMP, etc Lead continuous ... Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Sr. Manager , Third Party Manufacturing Working at Abbott At Abbott, you can do work… more
- Abbott (Alameda, CA)
- …with ISO, FDA design control standards or requirements. Experience managing compliance testing to EMC, safety, radio and other regulatory standards Expertise ... location in Alameda, CA, currently has an opportunity for a Technical Manager . The Technical Manager l eads a cross functional team in the development of new… more
