- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- …(21 CFR 820)), FDB, CA-RHB (Radiological Health Branch- product registrations, compliance , & licensing), Nuclear Regulatory Commission (NRC), Bureau of ... additional quality systems and compliance as required. Oversees the Regulatory Compliance Program, Corrective Action & Prevention Action (CAPAs) Program… more
- Merck & Co. (Rahway, NJ)
- …Accelerated timelines for site, filing, and launch readiness Improved access to product and process data Streamlined transfer of process and product ... and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- Formation Bio (New York, NY)
- …coordinating departmental and cross-functional support.Responsibilities Designs and implements regulatory strategies to obtain, maintain product investigative ... knowledge towards development of strategic and tactical plans. Identifies and assesses regulatory risks associated with product development for Formation Bio's… more
- Larimar Therapeutics (Philadelphia, PA)
- …achieve timely and efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements Evaluates proposed ... its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion… more
- Insmed Incorporated (NJ)
- …you?About the Role:We are seeking a highly experienced and visionary Vice President, Product Development - CMC, Small Molecules, to help us expand what's possible ... pipeline. As a senior leader, you will oversee drug substance and drug product development, analytical development, and combination product development. To be… more
- Merck & Co. (Rahway, NJ)
- …enable innovation.We are looking for an experienced professional with a strong IT - Product Management background to help us shape the vision and strategy of our ... software products in the clinical domain.The Technical Product Manager in this role should be able to...solutions that improve how we run clinical trials and regulatory submission for our patients, partners, and colleagues.As a… more
- Repligen (Waltham, MA)
- …and driven IT Business Partner to represent our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play ... efficiency, and enabling innovation across the bioprocessing manufacturing and product development lifecycle.This position requires strong collaboration with business… more
- Novo Nordisk Inc. (Boulder, CO)
- …programs to ensure product safety and quality Responsible for ensuring compliance with all regulatory requirements and maintaining the highest standards of ... Assurance (QA) function and serves as the leading expert in quality, compliance , and quality management systems (QMS). Provide direction & coordinate the Quality… more
- Eisai, Inc (NJ)
- …& Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Product Training Skills, ... If this is your profile, we want to hear from you. The Manager Product training is responsible for the following:- Developing and implementing training programs for… more
- SOFIE (Totowa, NJ)
- …from concept to reality-ensuring every process meets the highest standards of quality and regulatory compliance (21 CFR 211 and 212). If you're driven by ... pharmaceutical partners, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and… more
- SOFIE (Totowa, NJ)
- …pharmaceutical partners, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and ... an immediate difference? Step into a position that allows you to lead groundbreaking product development in a rapidly growing industry Job Description | Product … more
- USAA (San Antonio, TX)
- …us special and impactful. The Opportunity We are seeking a dedicated Development Product Owner Senior to support our Auto Modernization Development area. This role ... Owns and maintains a prioritized work backlog for one or more Agile teams. Product backlog includes complete user stories with acceptance criteria so that they are… more
- USAA (San Antonio, TX)
- …what truly makes us special and impactful. The Opportunity As a dedicated Development Product Owner Senior, you will serve as a direct representative of the business ... Owns and maintains a prioritized work backlog for one or more Agile teams. Product backlog includes complete user stories with acceptance criteria so that they are… more
- SOFIE (Somerset, KY)
- …and suggest logical modifications based on either scientific rationales and/or regulatory requirements. Identify compliance issues and process improvements ... PRODUCT SUPPORT SPECIALIST, RCM Title | Product...application of scientific principles and rationales and adherence to regulatory requirements. Collaborate with other production radiochemists and quality… more
- Keurig Dr Pepper (Frisco, TX)
- …needed for this role can be found in the full description below. Sr Principal, Product Owner - Enterprise Data Management Are you ready to redefine how data becomes ... and business transformation, this is your moment. Your Mission: As the Sr Principal Product Owner - Enterprise Data Management , you will execute the Data Operations… more
- Merck & Co. (Rahway, NJ)
- …products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. The role ... to improve processes related to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations.… more
- Sanofi (Swiftwater, PA)
- …are distributed throughout the world. This position guarantees the Quality and Regulatory compliance of products developed, manufactured and distributed by the ... the Quality head of the site with regards to product quality, safety and cGMP compliance as...the manufacturing activity based on evidences of GMP and Regulatory compliance . To define mandatory requirements to… more
- Merck & Co. (Rahway, NJ)
- …robust solutions and approaches are developed by working teams supporting the product .Compile with our company's Global and regulatory requirements and execute ... Process, Manufacturing Scale-Up, Process Improvements, Product Commercialization, Product Lifecycle, Product Management, Regulatory Requirements,… more
- Eisai, Inc (Durham, NC)
- …Engineering functions for artwork control and approval.Ensure consistency of labeling across product lines and compliance with Eisai policies and procedures and ... environments and requirementsSolid knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.Strong… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise ... trouble shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and… more
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