- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …health authorities. Represents DS in key interactions with Health Authorities. Ensures compliance of DS programs with regulatory requirements for diagnostics and ... centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to ... educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …supply chain of internal and external GMP manufacturing organizations.Ensures a satisfactory regulatory compliance level for these organizations for local and ... responsible for QA GMP activities pertinent to the overall compliance state of DS drug substance, drug product and...leadership to support the preparation, execution, and remediation of regulatory inspections of the sites. The incumbent leads a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the… more
- Merck & Co. (Rahway, NJ)
- …are completed with the highest regard for safety, quality and regulatory compliance .Qualifications:Education Minimum Requirement: This position requires either ... Job DescriptionDirector, Chemical Biotechnologies Description:The Director of Chemical Biotechnologies reports to the Senior Director Chemical Biotechnologies in… more
- Merck & Co. (Rahway, NJ)
- …are completed with the highest regard for safety, quality and regulatory compliance .Qualifications: Education: Degree in engineering or related pharmaceutical ... Job DescriptionDescription:The Director of Chemical Engineering R&D is responsible for...plant scale-up and activities to support technology transfer and regulatory filings. The incumbent will be responsible for the… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as… more
- Merck & Co. (Rahway, NJ)
- …Division, and Global Workplace & Enterprise Services (GWES) to ensure compliance with regulatory requirements, corporate standards, policies and procedures ... Job DescriptionPosition Description: Director Safety & Environment The Rahway Environmental, Health, and Safety (EHS) Director is responsible for development and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe US CA Veterinary Insights and Medical Affairs Director sets the strategic vision for the development, refinement, and implementation of veterinary ... of healthier animals in a highly competitive market.Reporting to the Executive Director , US CABU Professional Services, this position works closely with Marketing… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Merck & Co. (Durham, NC)
- …activities while ensuring product quality and optimized maintenance processes, regulatory compliance , employee and environmental safety, integration of ... our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support a new drug substance manufacturing operation's… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- …all functions of our company while driving improvements and alignment for regulatory compliance worldwide.Responsibilities: Manage and provide leadership to a ... and our neighbors are not impacted.This role, reporting to the Executive Director of Environmental Compliance , Sustainability & Stewardship CoE will manage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Catalent (Philadelphia, PA)
- …and guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance. ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function...delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Tris Pharma (Monmouth Junction, NJ)
- …use disorders, ADHD, etc.); Designs and implements clinical trials ensuring compliance with regulatory standards and industry best practicesOrchestrates and ... therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. The Executive/Senior...manages clinical aspects of regulatory strategies and actively engages with Food and Drug… more
- Insmed Incorporated (San Diego, CA)
- …York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Program Management, the Associate Director , Program Management ... accordance with the program strategy. In addition, the Associate Director of PM may be asked to lead and/or...& objectives by ensuring program work is conducted in compliance with PMO processes and Company policies and leading… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and ... Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and… more
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