- Merck & Co. (Rahway, NJ)
- …& Controls ( CMC) , Pre-approval Pharm will bring scientific and regulatory expertise, innovative approaches, and strong industry and FDA connections to our ... company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high-quality submissions for products that may include… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a ... are conducted and written in compliance with all cGMP regulatory as well as facility requirements. This individual will...Vision Plan with two plan options through VSP Life Insurance , Basic Life and AD&D and Supplemental Life … more
- Merck & Co. (Rahway, NJ)
- …device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical ... and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out,… more
- Laurel Health Care Company (Asheville, NC)
- …us with an attractive benefits offering: Competitive pay Medical, dental, and vision insurance 401K with matching funds Life Insurance Employee discounts Tuition ... the principles the Patient Driven Payment Model is required. Knowledge of regulatory standards and compliance requirements. Registered Nurse RN in the state. 50%… more
- Tris Pharma (Monmouth Junction, NJ)
- …development plans from first-in-human through late phase trials and regulatory filing. The role requires strong expertise in pharmacokinetics, pharmacodynamics, ... collaborate closely with clinical leaders, statisticians, bioanalytical teams, and regulatory affairs to inform key development decisions.Designs non-clinical in… more
- Merck & Co. (Rahway, NJ)
- …and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires ... and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and… more
- Merck & Co. (Rahway, NJ)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
- Merck & Co. (Durham, NC)
- …The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures related to EHS as ... of required reports to site, divisional and/or corporate management and regulatory agencies.Manage budgetary & capital needs to support EHS initiatives, projects… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-We are seeking a strategic and technical leader with ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… 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
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
- Merck & Co. (Rahway, NJ)
- …team of environmental, health and safety professionals, providing technical and regulatory support and implementation of all necessary measures and initiatives ... action.Lead site and/or local area audits for compliance with applicable regulatory requirements (ie OSHA, EPA, DEP, etc.). Translate Corporate and Divisional… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programsFoster… more
- Merck & Co. (Rahway, NJ)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide clinical pharmacology… more
- Merck & Co. (Rahway, NJ)
- …preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions. The successful ... development and validationFamiliarity with authoring relevant CMC sections of regulatory submissionsRequired Skills: Accountability, Accountability, Adaptability, Analytical Chemistry, Analytical… more
- BioAgilytix (Durham, NC)
- …ISO 27001).Oversee governance, risk, and compliance activities, including policy development, regulatory alignment (GxP/CLIA, GDPR, Part 11), and global data privacy ... vendor and third-party security risk, ensuring adherence to contractual and regulatory obligations.Define guardrails for AI and new technologies, including M365… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …member of the Technical Operations team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy ... continuous improvement.The Compliance Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …infrastructure, equipment, and systems support business goals and comply with safety, regulatory , and sustainability standards. This position is a key member of the ... knowledge of cGMP, ISO, or international clean room and pharmaceutical regulatory requirementsProven track record in supervising, mentoring, and coaching junior… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... dataProduce tables and graphics for inclusion in study reports and regulatory submissionsEnsure programmatic traceability from data source to modeling resultSupport… more
- Merck & Co. (Rahway, NJ)
- …experience of interacting with site, divisional or regulatory audits#MSJR #eligibleforerpRequired Skills: Communication, Continual Improvement Process, ... Manufacturing, Process Improvements, Product Formulation, Quality Management Systems (QMS), Regulatory Compliance, Regulatory Requirements, Safety Standards, Standard… more
