- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Regulatory Affairs - Regulatory ... provides planning and drives coordination of global and US regulatory activities. The Associate Director ...provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… 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 filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible… 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)
- …a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Regulatory Affairs - Regulatory ... provides planning and drives coordination of global and US regulatory activities. The Associate Director ...provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- Bristol Myers Squibb (Madison, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- AbbVie (Florham Park, NJ)
- …standards, including regulatory guidelines to meet customer needs. Qualifications Associate Scientific Director Qualifications + Bachelor's Degree in the ... level will be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior ... Director of Regulatory Affairs / Clinical Affairs in managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for assigned… more
- Scotiabank (New York, NY)
- Associate Director , Legal Counsel, Legal and Corporate Affairs **Requisition ID:** 206757 **Salary Range:** 180,000.00 - 211,800.00 _Please note that the ... advising the front office and other internal stakeholders on legal and regulatory matters related to the business. + Independently draft and/or assist the… more
- Organon & Co. (Jersey City, NJ)
- … in Organon Regulatory Chemistry, Manufacturing and Controls New Products, the Associate Principal Scientist ( Associate Director ) is responsible for ... molecule products in accordance with global regulations, guidance's and defined regulatory strategies. These products may be internal or acquired or licensed… more
- PSEG (Newark, NJ)
- …well as the attention, camaraderie and care for one another you might typically associate with a small business. Our focus on combatting climate change through clean ... political and lobbying activities of federal and state government affairs and other CC departments as needed. This role...including setting Board meeting agendas, working with the PEGPAC director to create the PEGPAC budget and manage all… more
- Veterans Affairs, Veterans Health Administration (Kings County, NY)
- …(QM) is a member of the executive administrative team and reports to the Director . The incumbent will work closely with the Chief of QM for ongoing oversight ... of care for the organization. Assumes a leadership role in facilitating regulatory compliance for internal and external oversight bodies (ie, The Joint Commission… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The HEOR Associate Director - BU based is accountable for ensuring execution of HEOR projects for priority pipeline programs, ... us. Job Description: Specimen Management Business Unit-JG5 **Position Summary** The HEOR Associate Director for the Specimen Management business is accountable… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Associate Director , Data Management is responsible for oversight of data ... management for clinical development studies within all MTPA therapeutic areas. The Associate Director works with departmental and cross-functional teams to… more
