- Larimar Therapeutics (Philadelphia, PA)
- …and efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements Evaluates proposed manufacturing ... 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
- 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)
- …and creating, developing, and administering in whole or in part, a training program which includes sales techniques and presentations, product and product ... & Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Product Training Skills,… more
- USAA (San Antonio, TX)
- …developers, testers and others to develop, implement and release in alignment with program and/or product road maps. Partners with sponsors, stakeholders, and IT ... impactful. The Opportunity We are seeking a dedicated Development Product Owner Senior to support our Auto Modernization Development...are consumable and testable by the Agile team or program . Reviews and accepts output of I/T and/or business… more
- USAA (San Antonio, TX)
- …developers, testers and others to develop, execute and release in alignment with program and/or product road maps. Partners with sponsors, stakeholders, and IT ... special and impactful. The Opportunity As a dedicated Development Product Owner Senior, you will serve as a direct...are consumable and testable by the Agile team or program . Reviews and accepts output of I/T and/or business… more
- Syner-G BioPharma Group (Boston, MA)
- …of manufacturing processes for compliance with quality and regulatory requirements.Provide technical support for the product /process lifecycle and ... and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …call monitoring Ensure strong collaboration with relevant cross-functional stakeholders Program Compliance : Develops recommendations and implements program ... team, Commercial Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality, Legal, Privacy and Finance. External… more
- Merck & Co. (Durham, NC)
- …activities for support of regulatory and customer inspections Provide compliance advice to site, development and commercial product teams Supports ... Systems (QMS), Quality Metrics, Quality Risk Assessment, Quality Risk Management, Regulatory Compliance Consulting {+ 5 more}Preferred Skills: Current Employees… more
- Merck & Co. (North Wales, PA)
- …Data Analysis, Data Management, Data Science, Numerical Analysis, Project Management, Regulatory Compliance , Regulatory Requirements, Scientific Leadership, ... clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.Independently… more
- Rolls Royce (Indianapolis, IN)
- …in product level safety boards and in-service reviews with regulatory and airworthiness authorities Provide technical support to help resolve technical queries ... and numerical methods Familiarity of the In-service operation environment, including regulatory and compliance requirements Experience of working on complex… more
- Merck & Co. (Rahway, NJ)
- …years of leadership experience with deep working knowledge of device, biologic/drug product , and process development including regulatory submission and approval ... Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes… more
- Insmed Incorporated (NJ)
- …risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk Assessments, ... years of Clinical Patient Care experience strongly preferred.A background in providing product defense before a national or international regulatory authority is… more
- Cipla (Hauppauge, NY)
- …for printed packaging materials to ensure accuracy, compliance with regulatory requirements, and alignment with product specifications. This includes labels, ... proper storage, handling, and inventory of printed packaging materials to maintain product quality and compliance . Ensure proper storage, labeling, and inventory… more
- Formation Bio (New York, NY)
- …to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support ... the appropriate identification, evaluation, and management of risks associated with product quality. Build strong relationships with regulatory agencies and… more
- Merck & Co. (Rahway, NJ)
- …within the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management ... leads and cross-functional partners to promote best practices.Prepare materials for program presentations for management review and regulatory submissions,… more
- Formation Bio (New York, NY)
- … vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and ... review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, and… more
- USAA (Plano, TX)
- …and leads all aspects of multiple initiatives in support of risk and/or regulatory compliance related initiatives including but not limited to: oversight of ... or quality governance. Applies a well-rounded understanding of risk and regulatory compliance to includes business strategies and solutions. Responsible… more
- Syner-G BioPharma Group (Boston, MA)
- …and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and ... automation systems.Maritime facilities background (preferred).Familiarity with GMP environments and regulatory compliance (preferred).LEED certification, PE license, or… more
- Merck & Co. (North Wales, PA)
- …the US improve patient experience, treatment adherence, and outcomes while maintaining compliance with the highest ethical and regulatory standards.- The ... cross-functionally with global and ex-U.S. commercial, medical, access, policy, and compliance stakeholders to ensure that Therapy Patient Programs (TPPs) outside of… more
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