- Lundbeck (Fort Wayne, IN)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Lundbeck (Waco, TX)
- …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 ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… 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 ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... or more years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials and creation of regulatory submission… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... in quality management in the pharmaceutical industry and quality (GxP) requirements Experience with process mapping, process redesign and SOP authoring/coordination… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global regulatory requirements for pharmaceutical ... personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP...have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision.Health Authority Interactions: Leads US FDA /EU EMA interactions with support from higher-level manager .Regulatory ... the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support,...the meeting minutes. This position develops awareness of global requirements through support of global submissions and this position… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and processes are verified and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross functional teams to ... candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with coordinating… more
- Genmab (NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which includes but ... in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA , EMA, and ICH guidance for drug development pertaining to… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... etc.Remain on the cutting edge of data readouts (consistent with FDA -approved labeling), medical congress meeting outputs and podium & symposia… more
- Eisai, Inc (Nutley, NJ)
- …Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate ... area need in terms of program development and propose/implement solutions. Requirements Bachelor's degree in computer science or related field required.Must have… more
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- Responsibilities: US Agent for all products, responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for ... new ANDA, NDA, IND and DMF for the US FDA in eCTD format. Preparation, Review and filing of...harmonization process of regulatory documentation at all manufacturing sites. Requirements : MS in Life Sciences. 4-5 years of proven… more
- Medtronic (Billerica, MA)
- …IT operations at Danvers and Billerica sites in Massachusetts. The IT Manager will drive operational excellence, optimize business performance, and maximize the use ... of contact for multi-site and plant leaders, the IT Manager will help unlock business value through IT capabilities...of the United States, a degree which satisfies the requirements of 8 CFR | 214.2(h)( 4)(iii)(A) and minimum… more
- Daiichi Sankyo, Inc. (Nashville, TN)
- …areas centered around rare diseases and immune disorders. Summary: The District Manager (DM) represents Daiichi-Sankyo to assigned customers. The DM hires, leads, ... Director, oversee the promotion of the assigned products consistent with the FDA label to assigned customers, using approved messages and resources. *Build, lead,… more
- Michael Page (Skokie, IL)
- …Oversight: Ensure all products comply with applicable regulations and standards, including FDA (21 CFR), FSMA, DSHEA, GMP, FTC, Health Canada, EFSA, and other ... health claims to ensure compliance with legal and regulatory requirements . Cross-Functional Collaboration: Partner with R&D, Quality Assurance, Product Development,… more
- Custom Goods (Carson, CA)
- Summary/Objective: In this role, the General Manager is responsible for the operation and financial performance by providing direction and leadership to exempt and ... and manages a comprehensive strategy for the facility by shaping requirements , assessing deliverables and utilizing resources to help eliminate process problems… more
- Central Garden & Pet (Dallas, TX)
- …Ensure our facilities manufacturing pet food and animal feed are compliant with FDA food safety regulatory requirements Responsible for creating and/or reviewing ... skilled and experienced Food Safety and Regulatory Affairs (FSRA) Manager to join our team! This position reports to...our team! This position reports to the Sr. Director, FDA Regulatory Affairs & Food Safety and will support… more
- Fresh & Ready Foods (Denver, CO)
- …? Job Summary: We are seeking an experienced and detail-oriented Transportation Manager to lead the daily operations of our food transportation network. This ... perishable and non-perishable food products to our customers. The Transportation Manager will lead routes, vehicle maintenance, and compliance with all… more
- Fresh Baguette (Germantown, MD)
- …savory creations delivered in a warm and inviting atmosphere. Packaging Operations Manager Job Summary: Fresh Baguette is seeking a Packaging Operations Manager ... followed. Stay updated on industry trends, sustainability initiatives, and regulatory requirements to keep Fresh Baguette at the forefront of packaging innovation.… more
- Bauer Consulting Group, Inc. (Schaumburg, IL)
- Position: Sanitation Manager Location: Schaumburg, Illinois area Qualifications: High School diploma or GED (Associate's degree preferred) Extensive Knowledge of ... SQF, BRC, FDA , USDA, OSHA, and MSDS. Experience keeping areas and...other departments to assure that food products meet the appropriate sanitation and Food Safety requirements . Bilingual (English /… more
