- Novo Nordisk Inc. (Plainsboro, NJ)
- …robust regulatory strategies required Experience interacting directly with regulatory authorities on an international scale Experience preparing teams ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …drug or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance ... Reviews and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as assigned Performs all job duties and… more
- Eisai, Inc (Nutley, NJ)
- …management concepts. Must have a detailed knowledge of domestic and international regulatory requirements (including ICH and GCP guidelines) Expertise ... TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements . Th is role also provides direction, leadership and training… more
- Insmed Incorporated (San Diego, CA)
- …of clinical research (Phase 1-3)Knowledge of ICH-GCP and FDA regulatory guidelinesDomestic and/or International travel required 20%Travel RequirementsDomestic ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global ... of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider… more
- Tris Pharma (Monmouth Junction, NJ)
- …that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in ... the US, have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes… more
- DivIHN Integration Inc (Atlanta, GA)
- …and/or presentation. Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and Client procedures (as ... Medical Advanced Surgery will write and edit clinical documents to support regulatory submissions for relevant products. The ideal candidates must have a scientific… more
- Aequor (Thousand Oaks, CA)
- …Board the labeling documents review/governance Represents labeling on product-specific global regulatory teams Leads the development and maintenance of core labeling ... competitor labeling, and labeling trends impacting the LWG and across the regulatory organization. Advises internal and/or external experts on the creation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(SOPs), Food and Drug Administration (FDA) regulations, EU Directives, and International Conference on Harmonization (ICH) guidelines. This role emphasizes the ... teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance: Understand study conduct from supply chain/drug forecasting… more
- Tris Pharma (Monmouth Junction, NJ)
- …that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in ... the US, have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic… more
- Aequor (Providence, RI)
- …diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory , Quality Assurance, Quality Engineering, International Quality and ... data and may serve as a primary author on regulatory filings and directly participate in and support site-based...analytical techniques General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing… more
- Novo Nordisk Inc. (WA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Washington, DC)
- …of experts.-Generate and sustain relationships with global thought leaders, US-based international policy think tanks, and consultants on key policy concerns ... public policy professional with at least 10 years' experience in international government affairs roles in governments, think tanks or business associations… more
- Merck & Co. (Rahway, NJ)
- …for generating and sustaining relationships with global thought leaders, US-based international policy think tanks, and consultants on key policy concerns including ... public policy professional with at least 15 years' experience in international government affairs in governments, think tanks or business associations responsible… more
- Merck & Co. (Rahway, NJ)
- …and review detailed statistical reports suitable for submission to health regulatory authorities, including the US FDA and international agencies.Primary ... diverse backgrounds and expertise, including research scientists, clinical scientists, regulatory experts, IT specialists, etc.Identify opportunities to add value to… more
- Tris Pharma (Monmouth Junction, NJ)
- …that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in ... US, have licensed our products in the US and international markets, and have a robust pipeline of innovative...Tris functions that contribute to the partnership, including R&D, Regulatory , CMC, Finance, Legal, and more. Understand their roles,… more
- Merck & Co. (North Wales, PA)
- … regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional ... or marketed vaccines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerationsPlanning clinical… more
