- DHL Express, Inc. (Erlanger, KY)
- …+ Participates in processing inbound freight for clearance through US Customs + Effectively processes shipments to gain clearance information while staying compliant ... with all government agency rules and regulations + Responsible for contacting DHL customers who are experiencing clearance delays with their shipments + Provides information to, and communicates with, DHL Origin and destination stations on the status of the… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- We are looking for a Director Product Counsel for the Regeneron Regulatory and Commercial Law team to provideetc. **Salary Range (annually)** $202,000.00 - $336,600.00 ... proactive and collaborative legal advice and counsel in connection with the commercialization of one or more of Regeneron's products, including support for our leading product in the allergic and inflammatory disease therapeutic area. Counsel will be embedded… more
- Kelly Services (Gillette, WY)
- …team is committed to transforming clinical care through the development of FDA -approved therapies, with a strong focus on stem cell research and commercialization. ... to shaping the future of healthcare. As a **Senior FDA Regulatory Affairs Specialist** , you will play a...collaborate with internal teams and external partners to ensure FDA compliance and successful product development from concept to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …of regulatory activities required of an IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio. These ... of original and/or supplemental applications and post marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as… more
- Alaka'ina Foundation Family of Companies (Fort Detrick, MD)
- …USAMRIID studies (GLP and non-GLP) that are to be submitted to the US FDA for regulatory decision making. + Work with Chief, RRA, Study Directors, principal ... and records associated with nonclinical studies, to include those conducted under FDA Good Laboratory Practice (GLP) requirements. + Perform quality review of… more
- Herbalife (Torrance, CA)
- …will be responsible for preparing and filing US import entries with Customs and the FDA . The Import Operations and Compliance Analyst will work with US Customs, the ... FDA , and the USDA for product clearance and release....CONTRIBUTE:** + File the entry with Customs and the FDA (if applicable) via ABI, includes managing and filing… more
- CVS Health (Raleigh, NC)
- …the US public health in collaboration with Food and Drug Administration ( FDA ), academic institutions, and other health insurance companies. The SS&C team conducts ... research, medical chart review validations, and pragmatic research using the FDA Sentinel Common Data Model (SCDM), Sentinel and Distributed Research Network… more
- BeiGene (San Mateo, CA)
- …The individual will have extensive experience with the United States FDA , oncology division, leading key interactions including supporting advisory committee (ODAC) ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge...and risk assessments, critical issue management and advice on FDA interactions. + Oversees the preparation of NA regulatory… more
- Ingersoll Rand (Durham, NC)
- …an experienced Production Manager to lead and optimize our manufacturing operations in an FDA 21 CFR 820 compliant environment, with a strong emphasis on quality and ... This role will focus on driving operational efficiency, ensuring compliance with FDA regulations, and overseeing production processes that meet the highest quality… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …(ie ANDAs, amendments, supplements, etc.) to the Food and Drug Administration ( FDA ) to ensure compliance with applicable regulations and guidance. + Prioritize many ... and risks to management appropriately. + Lead preparation for meetings with FDA including defining questions and all supporting information for Pre-ANDA meeting with… more
- University of Washington (Seattle, WA)
- …This position also supports the conduct of pharmaceutical sponsor-initiated, FDA -initiated, and institution-initiated audits of study data. Finally, this position ... and that ensure compliance with all aspects of Federal Drug Administration ( FDA ) and National Institutes of Health (NIH) regulations pertaining to clinical research… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …submits RAS Center regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory ... agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, maintains and organizes RAS Center Regulatory… more
- Actalent (Holly Hill, FL)
- …to employees, identify skill gaps, and recommend training opportunities. 3. Compliance with FDA Regulations, GMP & SOPs * Ensure all activities align with FDA ... Compounding, Blending, documentation review, quality assurance, batch record, gmp, Fda Top Skills Details Compounding,Blending,documentation review,quality assurance,batch record,gmp, Fda… more
- Houston Methodist (Houston, TX)
- …Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on ... regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases… more
- Hy-Vee Food Stores (West Des Moines, IA)
- …produced at Hy-Vee food-manufacturing facilities comply with applicable USDA and FDA food labeling regulations. Reporting Relations: Accountable and Reports to: ... and allergen statements to ensure compliance with USDA and FDA food regulations. + Manages regulatory review process for...+ Keeps up to date with evolving USDA and FDA regulation changes. Utilizes CFR database for verification of… more
- University of Michigan (Ann Arbor, MI)
- …agencies as appropriate to the Department of Pathology (eg, New York, California, FDA , etc.) + Suggests and helps implement training with regards to educating ... requirements, standards and best practices. + Oversee compliance with upcoming FDA Laboratory test development regulations. + Work closely with department… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …our team and lead clinical studies focused on cardiac biomarkers in an FDA -regulated environment. Job Description: We are seeking an experienced and highly motivated ... lead and oversee clinical studies focused on cardiac biomarkers in an FDA -regulated environment. The role involves planning, coordinating, and managing studies from… more
- Fresenius Medical Center (Waltham, MA)
- …in the interpretation and application of appropriate regulations. Responds to FDA or district office requests. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** Manage the ... viable product strategies and product submission. + Assists in interactions with the FDA and other regulatory agencies. + Builds professional relationships with the … more
- UNC Health Care (Lenoir, NC)
- …judgment and coordinates and supervises the activities to maintain FDA /ACR requirements. **Responsibilities** : + Performs quality radiographs on patients ... supervises all quality control tests to meet ACR and FDA requirements for digital mammography. + Ensures all quality...completed within the required parameters of the ACR and FDA . + Uses appropriate device to measure viewbox intensity.… more
- Boehringer Ingelheim (St. Joseph, MO)
- …for assuring compliance of validated systems, process, equipment to current cGMP, FDA , EU, USDA, BIAH and BI corporate requirements. This includes, but is ... + Develops and Maintains local standard operating procedures to follow all FDA /EU/USDA regulations, as well as Corporate procedures. + Serves on assigned internal… more
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