- 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 ... each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on… 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 ... we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …domestic, internal and external sites. In addition, this role will support Compliance initiatives , such as inspection readiness, metrics implementation and ... review, overall regulatory compliance and implementation programs, and others...provide commuter benefits, family planning and care resources, well-being initiatives , and peer-to-peer recognition programs - demonstrating our ongoing… 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 ... from Quality, Regulatory Affairs, IT, and Global Units Manage change initiatives to ensure successful adoption across global teams Continuous Improvement & … more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Associate Director , Compliance Operations will be a key member of Eisai's US Ethics & ... including vendor selection and onboarding Present updates to senior leadership on compliance trends, regulatory changes, and program enhancements C ontribute to… more
- Insmed Incorporated (NJ)
- …responsible for creating and implementing programs that ensure workplace safety, regulatory compliance , and environmental protection for all Insmed locations.Key ... consultants for instruction in subjects relating to health and safety and regulatory compliance (laws, regulations, requirements). Ensuring the proper execution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... initiatives for continuous quality improvement.Deputize for the Sr. Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive… more
- Insmed Incorporated (NJ)
- …Services Quality & Process leads quality assurance and process improvement initiatives to ensure compliance , consistency, and operational excellence across ... training, and data-driven optimization aligned with Insmed's strategic goals.The Associate Director , Patient Services Quality & Process is responsible for overseeing… 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 ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a key leadership...of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance: Ensure that… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional… more
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