- 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
- 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 (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 (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
- 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
- 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
- Cytiva (Pensacola, FL)
- …Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance , and aligning with organizational quality ... about the Danaher Business System, which makes everything possible.As the Senior Manager , Site Quality you will collaborate closely with cross functional leadership… more
- Leica Biosystems (Miami, FL)
- …Use Only (RUO) product development and sustainment.This position reports to the Senior Manager , Regulatory Affairs and is part of the Global Regulatory ... this role, you will have the opportunity to:Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and… more
- Cepheid (Miami, FL)
- …to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance .This position is part of the Quality ... compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union… more
- Cepheid (Miami, FL)
- …Post Market Quality, and other Quality related functions.This position reports to the Sr. Manager Regulatory Compliance and Post Market Surveillance and is ... in field with 2+ years of related work experience.Functional knowledge of Quality, Regulatory Compliance , and operations systems and processes to include GMP and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …enterprise AI and automation solutions that enhance workflows across Quality, Regulatory , and Clinical Affairs (QRC). This role blends project management, solution ... integration, and Generative AI.This position reports to the Senior Manager Innovation DBSL and AI and is part of...DBSL and AI and is part of the Quality, Regulatory and Clinical Affairs (QRC) team located in Chaska/Brea… more
- Leica Biosystems (Miami, FL)
- …the Manager , Quality Assurance and is part of the Quality Assurance and Regulatory Compliance Department located in Richmond, Illinois and will be an on-site ... finished products to ensure that product specifications and company and regulatory requirements are met. Investigates and troubleshoots functionality and performance… 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
