- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and ... audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA… 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
- 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
- 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
- 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 (Fresno, CA)
- …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
- 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
- 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
- Repligen (Waltham, MA)
- …Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate ... You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This...with eQMS systems or digital audit tools Familiarity with regulatory standards ( FDA , GMP, etc.). Excellent communication,… 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
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will ... way people monitor their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - International Compliance Operations** will… more
- J&J Family of Companies (Santa Clara, CA)
- …United States of America **Job Description:** Johnson & Johnson is hiring for a **Sr. Manager , Regulatory Compliance - Shockwave Medical** to join our team ... for the treatment of calcified plaque. **JOB SUMMARY** The Regulatory Compliance Senior Manager provides... requirements in the light of current guidance and FDA /International regulatory body field activity. **REQUIRED KNOWLEDGE,… 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 ... and ensures timely follow-up, closure, and reporting. Additionally, the manager supports the development, revision, and maintenance of Global...Functions: + Will be the contact person for the FDA and other regulatory agencies in regard… more
- Jabil (West Chester, PA)
- …globe. Are you experienced in Regulatory Compliance ? Jabil is seeking a qualified Regulatory Compliance Manager to work in West Chester, PA. As the ... Regulatory Compliance Manager , you will...Regulatory Compliance Manager , you will manage all ...audits: eg Notified Body, Ministry of Health country inspections, FDA , J&J Corporate Audits for site. + Audit preparation… more
- J&J Family of Companies (Irvine, CA)
- …States {+ 22 more} **Job Description:** Johnson & Johnson is currently seeking a Senior Manager , Source Regulatory Compliance to join our Regulatory ... position + Will establish, manage, maintain, and continuously improve Source Regulatory Compliance activities associated with assigned business Suppliers,… more
- Houston Methodist (Houston, TX)
- …**SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH and ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible...International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across… more
- Tecomet (Woburn, MA)
- …Serve as Official FDA Correspondent. + Serve as person responsible for regulatory compliance (PRRC). + Assist and complete site FDA /ISO/AS/EAR ... **TITLE** : Quality Assurance & Regulatory Affairs Manager **Department:** Quality Assurance... governance + Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market… more
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