- Bristol Myers Squibb (Princeton, NJ)
- …studies including FIH, and strategies in 14C human ADME studies. + Understanding of regulatory requirements in the areas of drug metabolism, drug - drug ... areas: + Experience in drug development, authoring drug metabolism reports for regulatory submissions. +... development, authoring drug metabolism reports for regulatory submissions. + In-depth understanding of the principles, theories… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription … more
- Merck (Rahway, NJ)
- …model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams.Collaborate with other functional areas, as well ... of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. + Educational background in… more
- Merck (Rahway, NJ)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... or a related field + At least 10 years of discovery/ drug development/ regulatory experience + Deep expertise in pharmacometrics (eg, population PK and… more
- J&J Family of Companies (Titusville, NJ)
- …/ DETAILED DUTIES:** + Assists Regulatory Affairs in the development of drug regulatory strategies + Helps explore and evaluate new product ideas to ... for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include project management, finance, legal, quality… more
- Merck (Rahway, NJ)
- …+ Experience with sterile GMP facility startup. + Knowledge of Investigational drug regulatory requirements. + Understanding of Clinical Supply Chain Operations. ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …pharmacology strategies and integrate them into clinical development plans to support drug development and regulatory packages **.** + Lead **clinical ... + Interact cross-functionally across other key disciplines involved in drug development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory… more
- Merck (Rahway, NJ)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... **Position Specific Required Skills and Experience:** + US and/or worldwide drug or vaccine regulatory application submission experience including the… more
- J&J Family of Companies (Raritan, NJ)
- …during the APPE may include, but are not limited to: + Support the management of regulatory or drug development issues + Gain knowledge of the US FDA regulations ... the Advanced Pharmacy Practice Experience (APPE) program in 2025 to support Global Regulatory Affairs (GRA). The APPE rotation will be based remotely. There are many… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …within the pharmaceutical or medical device industries, ideally with expertise in drug -device combination products; experience in regulatory and/or R&D, quality ... **Job Description Summary** As Regulatory Affairs Associate Director, you will be responsible...device project activities and new product development in Advanced Drug Development Delivery platform. You will be the primary… more