- 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
- 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
- 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
- Michael Page (Skokie, IL)
- …innovation, and integrity. Renowned for their steadfast commitment to quality, regulatory compliance , and consumer trust, they create cutting-edge products ... possible in the evolving landscape of health and nutrition. Job Description Regulatory Compliance Oversight: Ensure all products comply with applicable… more
- Envista (Brea, CA)
- …for assembling CE Technical files and final review of deliverables for MDR regulatory compliance with the goal of achieving notified body approval. This ... in designing and enhancing quality management systems to facilitate overall regulatory compliance . Responsible for authoring department standard operating… more
- EPM Scientific (San Diego, CA)
- …experience is preferred Responsibilities of the Manager include: Ensure compliance with evolving regulations, including FDA Medical Device Regulations and ... Title: Senior Specialist/ Manager of Regulatory Affairs Summary: A... compliance Review and approve product labeling, promotional materials, and advertising content to ensure adherence to regulatory … more
- Central Garden & Pet (Dallas, TX)
- … Manager to join our team! This position reports to the Sr. Director, FDA Regulatory Affairs & Food Safety and will support all applicable Central animal ... employees focusing on supporting our food safety initiatives and regulatory compliance . The position will also center...position will also center on supporting the Sr. Director, FDA Regulatory Affairs & Food Safety while… more
- Weee! Inc (Clifton, NJ)
- …is onsite 5 days a week in Clifton, NJ About the role The Food Safety & Compliance Manager responsibility is to assist the Director, Food Safety & Compliance ... knowledge of FDA (especially FSMA and cGMP rules), and USDA regulatory requirements HACCP and or PCQI certification Food Auditing Experience in manufacturing/… more
- Globus Medical (Audubon, PA)
- …needed for IDE and PMA reporting Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes Performs routine maintenance ... their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- State of Colorado (Denver, CO)
- …plans of correction and recommend certification level or revocation to the FDA through the certification program manager using standard reporting protocols. ... in diverse facilities to identify problems, violations or failures in compliance to laboratory certification manager . Minimum Qualifications, Substitutions,… more
- Strive Pharmacy (Mesa, AZ)
- …identify potential hazards and develop corrective actions to mitigate risks. Regulatory Compliance : Ensure compliance with OSHA, FDA , and other relevant ... Hybrid (2-3 days a week on-site at Mesa HQ) Position Overview: The Safety Manager is responsible for ensuring the safety and well-being of all employees, customers,… more
- Pernod Ricard (Louisville, KY)
- …on regulatory strategy in order to fulfil business objectives. Provide regulatory compliance support for NADL and Corby brands on labeling, manufacturing, ... marketing, and testing protocols. Evaluate and provide the regulatory compliance assessment for raw materials and...Regulatory Affairs/Quality Assurance with a focus on TTB, FDA and/or USDA food regulations preferred; ability to understand… more
- Olympus Corporation of the Americas (Minneapolis, MN)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Let's realize your potential, together. It is ... Documentation Practices based on OSTA QSR documents, ISO 13485, FDA 21 CFR 820. Meet deliverable, support and quality...law. Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs… more
- UWAJIMAYA INC (Seattle, WA)
- …following strengths: Have a deep understanding of food safety, facility operations, and regulatory compliance Know how to lead through influence and inspire ... maintenance, sanitation, and safety goals are consistently achieved while upholding regulatory compliance and promoting a culture of continuous improvement.… more
- T. Marzetti Company (Wareham, MA)
- …operations team in assessing all matters pertaining to product quality, food safety, and regulatory compliance and is seen as the senior technical leader at the ... staff and production teams on food safety, quality protocols, and regulatory compliance and develop/deploy accordingly. *Recommends and/or develops orientation… more
