- Merck & Co. (Millsboro, DE)
- …and Safety Management, Operations Management, Process Improvements, Process Manufacturing, Product Handling, Recordkeeping, Regulatory Compliance , Safety ... workshops, meetings, etc., as required to improve job skills and product -related procedures Education Minimum Requirement : High School diploma or equivalent… 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
- 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
- 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
- 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
- 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
- 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 (Philadelphia, PA)
- …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. (North Wales, PA)
- …Data Analysis, Data Management, Data Science, Numerical Analysis, Project Management, Regulatory Compliance , Regulatory Requirements, Scientific Leadership, ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… 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 (Fall River, MA)
- …time loss during any machine breakdown Prepare, review and update GMP documents to meet regulatory compliance and quality of product Prepare the facility and ... verifying it with the forecasts Ensure execution of new product & product transfer by performing gap...identification and analysis. Capable of handling and participating in compliance and regulatory audits at the local… 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 ... team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will… 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
- 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)
- …team, Commercial Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality, Legal, Privacy and Finance. External ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one... with Novo Nordisk and FDA requirements Responsible for Product Safety compliance across all Patient Support… 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
- Lundbeck (Bothell, WA)
- …Sciences in technology transfer activities to GMP manufacturing facilities, ensuring compliance with regulatory standards. Required Education, Experience, and ... October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration… more
- Cipla (Fall River, MA)
- …Support risk assessments and help mitigate any potential quality risks to product safety and compliance . Familiar with pharmaceuticals operation (preferably MDI) ... Request and Environmental monitoring etc. Preparation and review of the Annual Product Quality Review. Fulfil the requirement of regulatory submission while… 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)
- … 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
