- Merck & Co. (Millsboro, DE)
- …Thinking, Batch Record Review, Drug Product Manufacturing, Pharmaceutical Manufacturing, Product Release, Quality Mindset, Regulatory Compliance , USDA ... and gain competency in activities to ensure quality and compliance of product manufactured. The Senior Quality...GMP walk through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements Assistance… more
- Merck & Co. (Millsboro, DE)
- …scale-up decisions for freeze-drying cycles and integrated fill-finish operations that affect product quality, throughput, and regulatory compliance .Act as ... planning, batch record design, change control, deviations assessment, and regulatory file support.Translate complex scientific literature into actionable process… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory submission-related activities. Updates internal processes to ensure compliance with health requirements and expectations. Qualifications A Bachelor's ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… 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
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance: Ensure that all activities… more
- Merck & Co. (Rahway, NJ)
- …Senior / R5-equivalent - About the role We are hiring a Senior Product Manager to lead strategic development of our Integrated Printing and Plastic Manufacturing ... across both industrial software and automation/controls. You will set the product vision, align multi-year strategy with executive priorities, and partner closely… more
- Merck & Co. (Rahway, NJ)
- …Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory Compliance , Regulatory Inspections, Social Collaboration, ... in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in… more
- Insmed Incorporated (NJ)
- …meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all ... device combination product development at various development stages and product lifecycle management.Stay current with regulatory guidelines and industry… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... global regulatory strategy plans to facilitate efficient and driven product developmentMonitor the evolving regulatory competitive landscape to identify… more
- Merck & Co. (North Wales, PA)
- …and regulatory submission for our patients, partners, and colleagues.As a Technical Product Manager for the Compliance , Risk, Quality, & Vendor Management ... Stakeholders across the organization. Candidate will be accountable for the entire Compliance , Risk, Quality, & Vendor Management product from the prioritization… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Maintain learning management systems and track training completion rates to ensure compliance with safety and regulatory requirements Lead the development and ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...Evaluate training curricula and make adjustments based on feedback, compliance audits, and evolving regulatory standards Key… more
- Henkel (Rocky Hill, CT)
- …regulatory and product stewardship initiatives + Review and organize regulatory compliance documents, including scanning and archiving materials + Support ... product safety and regulatory compliance by gathering and analyzing health and safety data + Assist with pre-authoring Safety Data Sheets (SDS) and Hazard… more
- Merck & Co. (Rahway, NJ)
- … development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and ... verification testing strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design,… more
- Merck & Co. (Rahway, NJ)
- …executive level and build cross-functional partnerships.Solid understanding of security, compliance and regulatory requirements relevant to payments (PCI-DSS) ... end-to-end solutions for Manufacturing Finance processes (costing, production variance, product costing, inventory accounting, production planning integration, shop-floor interfacing),… more
- Novo Nordisk Inc. (Boulder, CO)
- …of technical teams required Experience working to standards required for regulatory compliance of Aseptic Processing facilities required Understanding of ... develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product manufacturing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …major programs or initiatives, and may function in a project leadership role Regulatory Compliance : Ensures compliance with all Federal regulations, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety/Quality/Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (Rahway, NJ)
- …for a health authority (particularly USDA-APHIS-CVB-IC and/or -PEL) as an inspector, product reviewer, compliance officer, other GMP/ regulatory role or ... Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director,... concerns.Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to… 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
- Eisai, Inc (Nutley, NJ)
- …experience preferred Participate in the development of brand business plans Ensure compliance with all regulatory , legal, and corporate guidelines in the ... Regulatory /Legal guidelines for healthcare provider interactions to ensure compliance . Experience working with and directing agencies and strategic vendors.… more
