- Merck & Co. (Rahway, NJ)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... device design control activities and documentation reviewsProvide evaluations of regulatory state of affairs of any devices...in certain states and cities within the United States . Final determinations with respect to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....the Oncology drug development preferred.Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA Travel Ability to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs ... maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The...in certain states and cities within the United States . Final determinations with respect to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience requiredExperience with ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience requiredExperience with ... immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to...applicable, partner companies for the development and approval of US , EU and global CCDS documents for regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... ethics-committees, and internal auditors in conjunction with CCQM, compliance, Regulatory ,-Pharmacovigilance (PV) and Medical Affairs .Responsible and supports… 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 ... regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and translational...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications...in certain states and cities within the United States . Final determinations with respect to… 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 ... the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and ... closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage...in certain states and cities within the United States . Final determinations with respect to… 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 ... the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a… 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 ... the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory ... unmet medical needs in North American markets. In the United States , MTPA launched rare diseases treatments...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on...you if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Merck (Rahway, NJ)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices...in certain states and cities within the United States . Final determinations with respect to… more
