- Haleon (Warren, NJ)
- …and + identifying emerging regulatory trends and evolving FDA expectations. **The Regulatory Affairs Co -Op Associate** The objective of the Regulatory ... providing visibility to potential gaps. In this role, the Co -Op Associate will be provided with the opportunity...wide format used for submissions to the FDA. The Regulatory Affairs Co -Op will be… more
- Haleon (Warren, NJ)
- …to join us. It isn't a question. **About the role** The **Sr. Manager Regulatory Affairs - Wellness** has responsibility for end-to-end regulatory activities ... + Bachelor's Degree. + 7+ years of experience with Regulatory Affairs . + 5+ years working specifically...for you and your family. We also offer the opportunity to receive a discretionary bonus based on the… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations )Provide clinical pharmacology ... Medicine Operations , Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout sites… more
- Merck & Co. (Rahway, NJ)
- …the Final Study ReportMaintain contact with all stakeholders (project leader, regulatory affairs , quality assurance etc.) and keeps them informed ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Organon & Co. (Jersey City, NJ)
- …Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, as well as ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Key Functions: Specific Responsibilities Evaluating pre-clinical… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be… more
- Parexel (Trenton, NJ)
- …GCTO Country Operations , other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is fully informed and prepared to ... **_Parexel FSP has an exciting opportunity for a Clinical Quality Operations ...well as preparing for, management and follow up of regulatory inspections. **Primary Duties:** Operational Quality Management: + Develop… more
- Organon & Co. (Jersey City, NJ)
- …collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations , regulatory affairs , chemistry, manufacturing and ... 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical and/or… more
- Eisai, Inc (Nutley, NJ)
- …field sales resources, and media assets. This role represents a key opportunity for a talented, passionate marketer to lead important and innovative commercial ... identify opportunities for optimization Provide support to Advocacy & Government Affairs teams for early AD patient identification screening initiatives Work… more
- Organon & Co. (Jersey City, NJ)
- …Research Epidemiology and Economics will report to the headquarters Director of Medical Affairs Outcomes Research. Focusing on Dermatology, in this role, you will be ... priorities. Developing and implementing patient-centred endpoints strategies, working with regulatory , Value Strategy Assessment (VSA's) and contracting. The role is… more
- Sumitomo Pharma (Trenton, NJ)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... new and established programs. This position reports to the Chief Medical Officer . **Job Duties and Responsibilities**...to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- Unilever (Hoboken, NJ)
- …as with the technical aspects of legislation, is the task of the UI Regulatory Affairs team. The team supports the whole Unilever International portfolio, deals ... activities and interacts with many functions in Unilever.The Unilever International (UI) Associate Regulatory Affairs Manager (Foods & Homecare) will be part of… more
- Sumitomo Pharma (Trenton, NJ)
- … Regulatory Affairs , Biopharma R&D. This position leads the Regulatory Affairs for biopharma R&D, report to the Chief Development Officer for ... Duties and Responsibilities** **_Regulatory Strategy_** + Develop and Manage Regulatory Affairs Strategy + Develop and gain... Regulatory matters in close partnership with the Chief Development Officer and other key stakeholders… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Sumitomo Pharma Co ., Ltd. is a global pharmaceutical company based...Regulatory Affairs (GRA) team based in the...prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission +… more
- Sumitomo Pharma (Trenton, NJ)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Sumitomo Pharma Co ., Ltd., is a global pharmaceutical company based...Global Regulatory Affairs (GRA) team based in the...prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission +… more
- J&J Family of Companies (Raritan, NJ)
- …We collaborate with the world for the health of everyone in it. Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter intern ... passionate about exploring a career in healthcare. **What's it like to be a Regulatory Affairs Summer Intern?** Gain hands-on, real world experience through an… more
