- 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 ... Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs -...the employment eligibility of all new hires in the United States . Please click on the following… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Leads US FDA/EU EMA interactions with support from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US /EU regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… 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 ... Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving… 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 … 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 ... the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources ( US , Brazil, Japan/ APAC and EU):in an efficient… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory ... regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle...compensation for roles that may be hired in the US . Actual compensation is influenced by a wide array… more
- Bayer (Whippany, NJ)
- …of brilliant and diverse minds to make a real difference, there's only one choice.** ** Director US Regulatory Affairs Liaison** The Director ... TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director US Regulatory Affairs...contact information below. Bayer is an E-Verify Employer. **Location:** United States : New Jersey : Whippany… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within Gilead's ... Global Regulatory Affairs organization and acts as a...conditions of the applicable plans. **For jobs in the United States :** Gilead Sciences Inc. is committed… more
- Bausch Health (Bridgewater, NJ)
- …CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for...compensation for roles that may be hired in the US . Actual compensation is influenced by a wide array… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... US FDA/EU EMA interactions with support from higher-level manager. + ** Regulatory Knowledge:** Demonstrates expert knowledge of US /EU regulatory … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... 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. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary:** Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products. **Responsibilities:** _CDx development_ _:_ Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Mount Sinai Health System (New York, NY)
- …5. Any duties within scope of ability assigned by department leadership. **About Us ** **Strength through Unity and Inclusion** The Mount Sinai Health System is ... dedication to delivering outstanding patient care. When you join us , you become part of Mount Sinai's unparalleled legacy...affiliated community health centers. We are consistently ranked by US News & World Report's Best Hospitals, receiving high… more
- Mount Sinai Health System (New York, NY)
- …Senior Director , Regulatory Compliance- Mount Sinai Health System** The Senior Director for Regulatory Affairs is responsible for assisting the Vice ... President, Quality and Regulatory Affairs , MSHS, in maintaining a state... reports to external agencies. + Works on other regulatory projects and duties as assigned. **About Us… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care...compliance with Sanofi's behavioral and ethical standards **Why Choose Us ?** + Bring the miracles of science to life… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** **Position Summary:** The Director of US Medical Affairs Agile Innovation is a ... leader responsible for agile acceleration of innovation across the US Medical Affairs function by deploying transformative...conditions of the applicable plans. **For jobs in the United States :** Gilead Sciences Inc. is committed… more
