- Merck & Co. (Durham, NC)
- …safe work environment with optimized product quality and manufacturing processes and regulatory compliance .The Associate Director of Engineering position ... be responsible for aligning maintenance projects with the business objectives around Safety, Compliance and Cost.- The Associate Director of Engineering must be… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory ... Ophthalmology. The individual functions with a degree of independence and provide regulatory oversight for assigned products in order to optimize product labeling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …monitoring functions, in support of Novo Nordisk's overarching global ethics and compliance program. Relationships Reports to the Executive Director , Risk ... Bachelor's degree and a minimum of twelve (12) years pharmaceutical, legal, regulatory , or compliance experience OR an advanced degree with a minimum of 10 years… more
- Repligen (Waltham, MA)
- …desirable.Experience:A minimum of 10 years of progressive experience in internal controls, SOX compliance , or related regulatory compliance roles within a ... OverviewRepligen Corporation is seeking a dynamic Controls & SOX Compliance leader. This is a high-impact, strategic role driving global compliance ,… more
- Merck & Co. (Boston, MA)
- Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving ... Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and guidance to RD PV QA on quality assurance practices and regulatory compliance .Keep abreast of evolving regulations and industry standards concerning ... centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV... and Quality OversightPlay a key role in ensuring compliance with regulatory requirements while driving innovative… more
- Merck & Co. (Boston, MA)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Eisai, Inc (Raleigh, NC)
- …more complex with the launch of biologic products and hhceco initiatives, the Director will oversee Global Logistics and Import/Export compliance for commercial, ... more complex with the launch of biologic products and hhceco initiatives, the Director will oversee Global Logistics and Import/Export compliance for commercial,… more
- Genmab (NJ)
- …and is a key driver for inspection readiness, regulatory compliance , and successful data submissions.The Associate Director will lead cross-functional ... or contribute to initiatives that improve operational efficiency, inspection readiness, and regulatory compliance .Act as a Data Standards or Clinical Systems… more
