- Parexel (Columbia, SC)
- …in a matrix organization. - Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. - Experience with flu campaigns, pandemic products, ... Join us as a **Global Labeling Operations Manager ** , where you'll...years of biotech/pharma industry experience, including 2+ years in labeling / regulatory operations with global responsibility. - Experience… more
- CSL Behring (King Of Prussia, PA)
- …therapies that make a meaningful difference worldwide. **Position Description Summary:** Regulatory leaders who leverage regional regulatory experience to ... actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus,… more
- Quad (Spartanburg, SC)
- …can always create a better way. General Purpose of Job The Quality Manager - Packaging oversees and coordinates the Quality Systems program across multiple ... policies, manages quality systems, and facilitates compliance inspections. The manager supports manufacturing, testing, and releasing of raw materials, semi-finished… more
- Cipla (Hauppauge, NY)
- …PowerPoint) and other relevant inventory/warehouse management software. Familiarity with FDA labeling requirements and other regulatory standards for packaging ... materials to maintain product quality and compliance. Ensure proper storage, labeling , and inventory management of printed packaging materials (labels, cartons,… more
- ASRC Industrial Services (Sacramento, CA)
- …function of this position is to manage hazardous waste site projects as a Response Manager or Project Manager (PM) in support of the firm's various cleanup and ... may also perform as a waste Transportation & Disposal Coordinator or Regulatory Specialist in support of other PMs from time to time. **RESPONSIBILITIES:**… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight travel ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- BeOne Medicines (Emeryville, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling ) and external stakeholders (eg FDA, MHRA, EMA, ... signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting. Physicians in this… more
- Parexel (Washington, DC)
- …while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior Physician in Patient ... working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client's guidelines and procedures, and… more
- Endo International (Hobart, NY)
- …we serve live their best life. **Job Description Summary** The Senior Manager Quality Assurance oversees, manages, and ensures the successful day-to-day operations ... APR/AR, Change Control, CAPA, and KPI Metrics). The Senior Manager ensures the success of the teams by oversight...Quality Assurance groups successfully issue and control labels and labeling confirming that issuance is on time and accurate.… more
- Lundbeck (Deerfield, IL)
- …ordering systems, tracking, and reporting. Additionally, in partnership with Regulatory Affairs, Promotional Review Committees (PRC/MLR), and Marketing, this role ... submission records, reference numbers, and archives per internal SOPs and regulatory requirements. + Ensure monthly Social Media reports are reviewed, updated… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care Compliance. **Job Duties** ... provides Medical Safety review and approval for PMS documentation, labeling /IFU creation, Clinical Evaluation Reports, developing responses to inquiries from… more
- Kerry (Vesper, WI)
- …for the Vesper Plant by monitoring sample delivery, correct logging and labeling , compositing, and retaining samples. Ensure that laboratory procedures, methods, and ... Responsibilities + Understand and comply with all HACCP, allergen, environmental, regulatory and customer demands and requirements. Keep detailed and accurate… more
- ALBEMARLE (Charlotte, NC)
- …**What You Will Do** + Work and effectively communicate with a project manager and team of engineers of differing disciplines to execute assigned projects. + ... the complexity of the installation. + Ensure that all labeling and PSSR requirements are complete and accurate prior...or as needed to ensure compliance with industry and regulatory requirements. + Expected to possibly travel domestically only… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be ... and/or related experience. + Knowledge of US and EU product labeling regulatory requirements and guidelines. + Familiarity with US and/or EU regulatory… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Strategic Global Labeling Manager in Regulatory Affairs is responsible for ... changes and process the labeling in accordance with internal labeling procedures. + Maintain documentation within regulatory information management system.… more
- Parexel (Des Moines, IA)
- …in a matrix organization. * Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. * Experience with flu campaigns, pandemic products, ... Join us as a **Global Labeling Operations Manager ** , where you'll...years of biotech/pharma industry experience, including 2+ years in labeling / regulatory operations with global responsibility. * Experience… more
- Boehringer Ingelheim (Ridgefield, CT)
- … for NCEs/NBEs and labeling supplements, in conjunction with the assigned RA Labeling Content Manager and Product Manager in the RA Product Groups. ... labeling initiatives in compliance with Corporate and local regulatory requirements. The AD, DRA Product Labeling ...to be able to properly understand the implications of labeling decisions throughout the business Manager : +… more
- Taiho Oncology (Pleasanton, CA)
- …environment. + Minimum 7 years' experience in pharmacovigilance, drug safety, or regulatory labeling within the pharmaceutical or biotechnology industry. + ... a transformative journey with Taiho Oncology as a Senior Manager , Global Labeling and PV Operations. At...and others) are current, accurate, and compliant with global regulatory requirements for ICSR assessments. The position also supports… more
- Danaher Corporation (Miami, FL)
- …Intern will gain hands-on experience and exposure in the critical area of regulatory labeling within the medical device and Life Sciences industry. Interns ... projects to meet FDA, EU, IVDR, ISO, CLP/GHS, and other countries' regulatory requirements. . Support the management of labeling change control processes,… more
- Compass Group, North America (Oak Creek, WI)
- …routine Food Quality Program/SQF tasks. * Works in tandem with the QA Manager and assists in developing, writing, and implementing SOPs and driving continuous ... food safety culture. * Technical knowledge and experience in Food Safety and regulatory requirements. * Experience maintaining or implementing an SQF system in a… more
