- Aequor (Newbury Park, CA)
- …organization. To coordinate and execution of US regulatory submissions with the US Regulatory Lead in compliance with corporate standards and local ... US regulatory submissions To assist the Global Regulatory Lead to manage GRT interactions The...Develop Regulatory Position with GRT Actively support regulatory compliance Support the development and execution… more
- Merck & Co. (North Wales, PA)
- …Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc ... Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership… more
- Merck & Co. (Rahway, NJ)
- …and implement continuous improvement strategies for device quality and regulatory processes.Monitor and ensure compliance with global regulations ... regulatory strategy.Drive operational excellence initiatives that improve quality, compliance , and organizational efficiency.Liaise with external partners, suppliers, and… more
- Daiichi Sankyo, Inc. (Bernards, 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...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Merck & Co. (Durham, NC)
- Job DescriptionLead Technician, Calibration and Maintenance (O4) Lead Maintenance Technician will be a leader with strong interpersonal, communication, and ... in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.The… more
- Merck & Co. (Rahway, NJ)
- …critical business needs, which can include impact of the external business, regulatory , and compliance environment. Promoting our company's scientific excellence ... exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience...the AR&D organization in aspects of quality control and compliance . Your main responsibilities will include: - Strategy and… more
- Merck & Co. (Rahway, NJ)
- …product presentations and be familiar with current industry and regulatory standards/best practices and innovative approaches for demonstration of container-closure ... investigations and deviation (OOS & OOT) management.Strong knowledge of current global regulatory standards and best practices related to all aspects of CCIT .Proven… more
- Eisai, Inc (Nutley, NJ)
- …assesses and provides objective risk assessments and guidance regarding Eisai's compliance with regulatory , organizational, and commercial requirements that ... compliance initiatives (strategic and execution).Assess and guide on compliance with regulatory , organizational, and commercial requirements.Define and… more
- Merck & Co. (Rahway, NJ)
- …Potentially manage other RaDS architecture and engineering team members.Ensure ongoing compliance with regulatory safety, Good Practice (GxP) and Validation ... and fantastic user experience.You will be responsible for identifying opportunities that lead to the growth of our products through constant improvement and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Merck & Co. (Boston, MA)
- …and advance the drug discovery and development pipeline.As an IT Product Technical Lead within the Disease Biology and PharmTox (DBPT) Product Line, you will enable ... an eagerness to learn drug discovery & development processes and regulatory requirements as necessary to solve problems.Education Minimum:Minimum of a BA/BS… more
- Merck & Co. (Rahway, NJ)
- …in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations. This may include review of documentation and ... deviation investigations, ensure permanent inspections readiness, regulatory inspection support and monitoring, change control oversight and management, metric… more
- Merck & Co. (South San Francisco, CA)
- …as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also work closely with therapeutic area ... immuno-metabolic, and cardiovascular diseases to enable a robust drug discovery pipelineDrive hit/ lead finding and lead optimization plans in collaboration with… more
- Merck & Co. (South San Francisco, CA)
- …in translational cell models, mechanistic pharmacology, and biomarker and lead discovery to join our Quantitative Biosciences (Pharmacology) department. The ... experimentation to advance early drug discovery projects from target concept through lead optimization. The candidate will work closely with a team of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enhance TA-specific customer experiences; building strong cross-functional relationships; ensuring compliance to Legal, Regulatory and industry standards; ... Best Practices: Maintains strong understanding of omnichannel best practices, Marketing and Regulatory /Legal aspects to ensure compliance with legal, quality and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QA Investigations Lead (1st or 2nd shifts) as part of the Quality team based in ... Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell therapy to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … compliance with company policies, cGMP, safety standards, and regulatory requirements.Operate equipment on the production line via aseptic technique within ... Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Merck & Co. (Durham, NC)
- …Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… more
