- Eisai, Inc (Nutley, NJ)
- …including 8 years of direct Regulatory Affairs experience with new/innovative drug registration strategy/submissions. Advanced degree (Master's or PhD) is a plus.Any ... management in both CTD format and non-CTD format.Experience of the Drug Development process and working with cross functional international/global project… more
- Aequor (Thousand Oaks, CA)
- …Chemistry, or Bio Processing degree is preferred. Chromatography.The Pivotal Drug Substance Technologies organization at develops, characterizes and supports ... clinical drug substance manufacturing processes for all late-stage programs in...degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with a demonstrated record of excellence.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This is ... with IRT systems and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross functional and on Global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cGMP requirements, as well as according to state and federal regulatory requirements. Other duties will be assigned, as the need arises.Job duties performed routinely ... on-time.Duties are required to be performed on-site at manufacturing facility.Perform other duties as assigned.Attend departmental and other scheduled… more
- Insmed Incorporated (NJ)
- …inhalation products a plusSignificant experience in interactions with FDA, EMA, and other global regulatory agenciesDeep understanding of the drug development ... to Work list in the UK.For patients, for each other , and for the future of science, we're in....the global regulatory lead for documentation review prepared by other technical functions and will act as the primary… more
- Cipla (Fall River, MA)
- …reports of method validations / verifications / comparison reports and any other study reports. Monitoring and ensuring of current Good Laboratory Practices (cGLP) ... for timely submission as part of new and existing abbreviated new drug applications (ANDAs). Maintaining all the incoming documents with proper tracking, recording,… more
- Merck & Co. (Rahway, NJ)
- …risks worthy of escalation versus typical uncertainty associated with drug development, commercialization, and/or supply. Productive Communication:-- Plans and ... Management, Cross-Cultural Awareness, Cross-Functional Leadership, Cross-Functional Teamwork, Decision Making, Drug Development, External Manufacturing, GMP Compliance, Innovation, Leadership, Life… more
- Merck & Co. (Durham, NC)
- …(2-2-3). - - The role of Operations Manager at our Company's Durham drug substance manufacturing facility is a manufacturing leadership role. The individual in this ... Successful candidate(s) will be assigned to support the purification of the drug substance for the vaccine.- -Responsibilities include, but are not limited to:-… more
- ACROBiosystems Inc. (San Jose, CA)
- …and manufacturing recombinant proteins and critical reagents/assays to support drug development and clinical applications from target discovery and validation, ... candidate drug screening and optimization, CMC development, preclinical and clinical...the territory up to 40–50% of the time. Perform other duties or special projects assigned. Minimum Qualifications –… more
- Eisai, Inc (Nutley, NJ)
- …on both operational and strategic aspects of labeling.Responsible maintaining the Drug and Establishment Listings for all of Eisai's products.Maintain centralized ... stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities. Represent the Global Labeling group on Regulatory… more
