- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... development of regulatory strategies to ensure effective achievement of regulatory /business objectives. The Executive Director will direct the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and approvalsExtensive experience developing companion diagnostics and devices.Experience of drug development and drug regulatory procedures.Understanding ... of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device...deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.Experience with developing… more
- Koch Industries (Wichita, KS)
- …engineering and sales offices in 25 countries. KES is hiring a Global Compliance Director in Wichita, KS to lead its worldwide compliance capability. As the Global ... Compliance Director for KES, you will play a critical role...role requires a strategic thinker who can navigate complex regulatory environments, collaborate across businesses and functions, and implement… more
- Mirum Pharmaceuticals (San Mateo, CA)
- …be real, get it done, and have fun, seriously. POSITION SUMMARY The Associate Director , Global Regulatory Affairs provides management of all aspects of assigned ... industry standard practices. Experience with health authority negotiations. Experience with regulatory submissions (eg New Drug Applications (NDA/NDS/MAA), post… more
- Bausch Health (Bridgewater, NJ)
- Director , Regulatory Affairs (Global Labeling) Job Location: Bridgeport, Connecticut, USA | Danbury, Connecticut, USA | Fairfield, Connecticut, USA | Hartford, ... skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy, to… more
- Merck & Co. (Rahway, NJ)
- …and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and ... team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …our office three days per week on average. Position Summary The Associate Director , Regulatory CMC, is responsible for contributing to/assisting with the ... regulatory requirements, processes, and logistics to conduct global drug development and commercial activities. Primary Responsibilities Supports CMC … more
- Eli Lilly and Company (Washington, DC)
- …that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of the Associate Director - Global ... determined to make life better for people around the world. Purpose: Global Regulatory Policy & Strategy strives to enable Lilly to deliver innovative regulatory… more
- Merck & Co. (Rahway, NJ)
- …of novel small molecules, biologics, and vaccines for infectious diseases. The Associate Director is a skilled quantitative drug developer, with a strong, ... integrated understanding of the strategic elements of drug discovery and development. The Associate Director should demonstrate collaborative work spirit and… more
- Merck & Co. (San Francisco, CA)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... Pharmacokinetics, Pharmacology, Pharmacometrics, PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills: Drug Discovery Process, Global Regulatory , Machine Learning,… more
- Merck & Co. (South San Francisco, CA)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... informed drug discovery and development for programs .-The Senior Director in Pharmacometrics should provide strategic leadership for pharmacometrics through the… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership...stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory… more
- Merck & Co. (Boston, MA)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... with ability to understand how MIDD can drive portfolio and regulatory decisionsDeep knowledge of drug development, pharmacokinetics and pharmacology… more
- OneOncology (Chattanooga, TN)
- Director , Drug Development Unit Tennessee Oncology Chattanooga, TN Job Details: Occupation: Director , Drug Development Unit Specialty: ... APPs About the Role: Tennessee Oncology is seeking a Director of a new Phase I unit in Chattanooga....will be responsible for the scientific leadership of this drug development unit including study selection, patient enrollment, study… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at Eisai. This Executive ... Director will lead franchise programs, and will be the...opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase… more
- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the clinical...and technical progress within the field of biostatistics in drug development and advise of new methodologies that may… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be... Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Merck & Co. (Rahway, NJ)
- …operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances and finished products. As Director , you will ... Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to...implementation and effectiveness to ensure no recurrence of findingsGather regulatory intelligence and partner with our Company and CMO… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
