- Merck & Co. (Rahway, NJ)
- …collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to ... Job DescriptionJob Summary: The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization.… more
- Insmed Incorporated (San Diego, CA)
- …global regulatory strategy plans to facilitate efficient and driven product developmentMonitor the evolving regulatory competitive landscape to identify ... area (Master's/PhD/PharmD) preferred. RAC certification desired10+ years of experience in Regulatory Affairs, and product development experience within the… more
- Insmed Incorporated (NJ)
- …global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory ... pre-clinical, and lifecycle management activities for assigned programsIdentify and assess regulatory risks associated with product development and define… more
- Merck & Co. (Rahway, NJ)
- …technology transfer, problem-solving and working collaboratively with receiving sites, drug product partners,and Technical Product Leaders, regulatory and ... to support global and site-specific projects, facilitate technologytransfer, and drive product robustness for sustained launch in alignment with the company's… 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...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Tris Pharma (Monmouth Junction, NJ)
- …functions and new product development processes (ie, Compliance, R&D, Product Development, Regulatory Affairs, Government Affairs, etc.)Ability to influence ... to inform related strategies for development of 505(b)(1) and 505(b)(2) product applications and/or potential product acquisitionsAssists in assessing and… 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)
- …device combination product development at various development stages and product lifecycle management.Stay current with regulatory guidelines and industry ... Regulatory Agencies as the lead in agency interactions and product development meetings.Understanding of scientific principles and regulatory CMC… more
- Cipla (Hauppauge, NY)
- …the integrity, compliance, and performance of IT systems, contributing directly to product quality and regulatory adherence. You will primarily be responsible ... ensuring that all system actions are secure, traceable, and compliant with regulatory standard. Review of the batch records (manufacturing and packaging) to ensure… more
- Merck & Co. (Millsboro, DE)
- …Batch Record Review, Drug Product Manufacturing, Pharmaceutical Manufacturing, Product Release, Quality Mindset, Regulatory Compliance, USDA Regulations, ... Job DescriptionThe Senior Quality Specialist ensures product /process quality system adherence and batch record review,...to cGMPs and is knowledgeable in federal and other regulatory agency requirements and other regulatory agency… more
- Merck & Co. (Millsboro, DE)
- …decisions for freeze-drying cycles and integrated fill-finish operations that affect product quality, throughput, and regulatory compliance.Act as the internal ... planning, batch record design, change control, deviations assessment, and regulatory file support.Translate complex scientific literature into actionable process… more
- Aequor (Thousand Oaks, CA)
- …Standards Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (eg FDA CFRs for ... a streamline and modernized Quality Management System to handle the increases in product volume and complexity across the enterprise (R&D, Operations, and GCO). In… more
- Dr. Oetker (Naperville, IL)
- …our Food and non-Food portfolios. You will work intra-departmentally with Regulatory Compliance and Innovation/ Product Development, and cross-functionally with ... suppliers while driving compliance and performance. Work closely with Sourcing, New Product Development (NPD), Regulatory , and cross-functional teams to drive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …strategies to ensure successful development of CMC submission packages to support product life cycle management.Work effectively with regulatory colleagues and ... the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval… more
- Merck & Co. (North Wales, PA)
- …acquisition/integrations, SAP system upgrades, 3PL Distribution Transitions, Key Product Launch Initiatives, Legal/ Regulatory (340B) Adherence Initiatives).- ... - Core Responsibilities - As a member of the Product Launch Team, this role evaluates the impact to...role evaluates the impact to the Channel Agreements of product supply and launch of new products to meet… more
- Novo Nordisk Inc. (Boulder, CO)
- …develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product manufacturing ... projects. The position will manage CMO's to ensure the continuous supply of product and apply risk mitigation strategies, as well as perform formulation studies in… 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)
- … 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. (North Wales, PA)
- …and enable innovation.We are looking for an experienced professional with a strong Product Management background to help us shape the vision and strategy of our ... software products in the clinical domain.The 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
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