- Tris Pharma (Monmouth Junction, NJ)
- …Complaints (PQC) documentation, compliance efforts, quality operations, etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA , as well as all ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and the FDA . Monitors and ensures company compliance with regulatory standards.Excellent organizational and communication skills.#Li-JK2#Li-HybridLegend ... Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Partner with all operations work-cells to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes.Serves as ... Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team...(SME) in preparation for and during internal and external regulatory audits (including FDA , EMEA).Responsible to maintain… more
- Lundbeck (Greensboro, NC)
- … regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability ... lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-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...relationships may include Convention Marketing and Sales Training. The Manager may represent Medical on PRB working group, brand… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriatelyDemonstrates advanced knowledge of processes related to clinical studies, regulatory issues, CRO operations, and compliance practicesInteracts ... centered around rare diseases and immune disorders. Job Summary The Study Associate Manager , under the guidance of the Associate Director, will supervise a group… more
- Lundbeck (College Station, TX)
- …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 (Oakland, CA)
- …transform lives. Join us on our journey of growth!As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA , GLP, QSR, cGMP, USP, and CDR ... performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive ... clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …QA experience Experience in a licensed drug or biologic facility regulated by the FDA , EMEA or a leading international regulatory agency preferred As applicable, ... reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… 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
- University of Michigan (Ann Arbor, MI)
- HLD & Regulatory Compliance Manager Apply Now **Job Summary** The High-Level Disinfection (HLD) and Regulatory Compliance Manager oversees fiscal ... not limited to The Joint Commission, CDC, OSHA, CMS, FDA , AORN and AAMI. Ensures continual accreditation readiness with...Detail** **Job Opening ID** 256715 **Working Title** HLD & Regulatory Compliance Manager **Job Title**… 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...sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across… more
- Houston Methodist (Houston, TX)
- …and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for ... study specific processes under the direct supervision of the Regulatory Compliance Manager **QUALITY/SAFETY ESSENTIAL...+ Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA ,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- * Manager , Regulatory Affairs Date: Apr 2, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 61105 **Who we are** ... a difference with. **How you'll spend your day** The Manager , Regulatory Affairs will: + Prepare, review...amendments, supplements, etc.) to the Food and Drug Administration ( FDA ) to ensure compliance with applicable regulations… more
- Abbott (Lake Forest, IL)
- …location in **Lake Forest, IL** has currently an open position for **Quality Systems, Regulatory Compliance Manager ** . This person will be responsible for ... Monitoring, Nonconformance/ CAPA, and PRRC (Person Responsible for Regulator Compliance ). Directs multi-site, Division-wide activities to accomplish quality system… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Description The Sr Manager Regulatory Affairs represents US regulatory affairs for ... primarily for US regulatory filings, ensures technical accuracy, and regulatory compliance . Ensures that applications are executed appropriately and… more
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