- Merck & Co. (Rahway, NJ)
- …and regulatory postureDemonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC.- Strong experience in safety and environmental ... Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Merck & Co. (Rahway, NJ)
- …and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative ... enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve as the primary technical contact… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Insmed Incorporated (San Diego, CA)
- …technology transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance, and supporting audits are also ... lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of… more
- Merck & Co. (Rahway, NJ)
- …and change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Sciences, Phytochemistry, Process Control Automation, Process Optimization, Process Simulation, Product Formulation, Safety Compliance, Standard Operating Procedure… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and… more
- Merck & Co. (Durham, NC)
- …Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).- Supply Chain Management:-Manage coordination with ... Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director).-This role serves as a Virtual Plant Manager - responsible… more
- Merck & Co. (Durham, NC)
- …role will contribute to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend coverage will be ... with a team of individual contributor production direct reports including safety , quality, and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Aequor (Hicksville, OH)
- …line and monitors for defects. Inspects filled container or package to ensure product is according to specifications. May weigh finished products to detect missing ... line culls and documents all components discarded. Prepares shippers, inspects finished product and packages into shipper. Seals, labels, and stacks shipper. Fills… more
- Aequor (Tampa, FL)
- …to management and correct where possible. Stop work where deemed necessary to maintain safety . 3&plus years' experience Education: Associate 's degree or higher ... and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples. Perform… more
- Eisai, Inc (Phoenix, AZ)
- …Oncologists, Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product (s) consistent with FDA approved label. ... understanding of issues and opportunities in territory. Deliver clinical, efficacy, and safety messaging and information about product access / safe… more
- Smithfield Foods, Inc. (Wichita, KS)
- …safe handling of food by recording and analyzing critical control point records that track product through the plant ensuring the safety of food products at all ... times. Properly review and scrutinize all aspects of the food safety system and meat production processes. USDA Regulatory Requirements Ensure the USDA … more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …inserts and structured product label. Medication guides. Container labels. Core safety data sheets Maintaining Regulatory archive of product labeling ... that are making a real impact on patient outcomes. Job Summary: The Associate Director of Post-Marketing is responsible for providing management of a post-marketing … more
- Miltenyi Biotec (Waltham, MA)
- …established signal assessment strategy; assess potential impact on the Miltenyi Biomedicine product safety profile with recommendation for action and initiate ... to Chief Medical Officers (CMO) for assigned products, the Associate Medical Director/ Medical Director AMD/MD, Safety ...to assigned Safety Management Teams. Advise on safety concerns. Contribute to regulatory responses to… more
- Abacus Service Corporation (Princeton, NJ)
- …eCTD submission, electronic document lifecycle, system validation and to review regulatory affairs submissions documents electronically to ensure all Regulatory ... review and approval of OPDP submission documents such as Important Safety Information (ISI) electronically and/or manually. *Create and maintain Submission ready… more
- System One Holdings, LLC (Cranbury, NJ)
- Job Title : Food Safety & Regulatory Compliance Specialist Location : Cranbury, NJ Hours / Schedule: Monday - Friday, 8am - 4pm, onsite Type: Direct Hire ... Responsibilities The Food Safety & Regulatory Compliance Specialist is responsible...time. Handle all customer inquiries related to documentation and product information with efficiency and precision. Manage new suppliers… more
- HelloFresh (Aurora, IL)
- Role: Associate Director of Food Safety Location:...The FSQ team is the core of ensuring food safety and high product quality. Producing high ... plating ready-to-eat meals requires excellence in food handling and environmental cleanliness. The Associate Director of Food Safety will set the agenda and… more
- Ascend Wellness Holdings (Ann Arbor, MI)
- …a cannabis dispensary for you, APPLY TODAY! JOB SUMMARY The Dispensary Associate is responsible for guiding customers through the cannabis purchasing experience, ... oriented, and compliant with established policies and procedure Continuously develop product knowledge to offer customers the most up-to-date information and advice… more
- Winn-Dixie Retail Stores (St. Petersburg, FL)
- …food handling practices, sanitation and productivity are maintained. Adheres to all regulatory compliance requirements pertaining to food safety , United States ... necessary safety training. Ensures Hazardous Assessments are posted for associate reference and that Personal Protective Equipment is available and utilized by… more
