- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight. This role fulfills the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews systems… more
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight. This role fulfills the… 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
- Lundbeck (Fresno, CA)
- …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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management.… 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
- 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
- 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
- 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
- DRT Strategies, Inc. (MD)
- …to achieve project goals and make vision a reality. Project Description: The FDA is composed of multiple Centers and Offices. Each Center/Office at FDA ... and efficiently support each Center's and Office's mission critical work. The FDA CIO's office, Office of Digital Transformation (ODT), along with the Center's… more
- Tecomet (Woburn, MA)
- …related to Aerospace and Defense (ITAR/EAR/AS 9100) + Conduct ongoing company-wide trainings on FDA and ISO requirements . + Manage the CAPA process and ensures ... **TITLE** : Quality Assurance & Regulatory Affairs Manager **Department:** Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports To:** Senior… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced ... from the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s)… more
- Kedplasma (College Park, GA)
- …KEDPLASMA SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other regulatory ... within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...requirements . + Holds regular meetings with Quality Assurance Manager (QAM) and Center staff for revisions and updates… more
- Perdue Farms, Inc. (Lewiston Woodville, NC)
- …Hygiene by following and ensuring strict enforcement of Perdue Farms Standards, USDA, FSIS, FDA , GFSI, OSHA and customer requirements . + Leads or participates in ... **Summary** We are actively recruiting for an experienced Sanitation Manager for our Lewiston Harvest facility. This position will... Proficiency** + Capable of incorporating applicable USDA / FDA /FSMA requirements into plant procedures as… more
