- 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.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience… 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 ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… 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 ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents. Partners with Study Manager on study deliverables.Participates in… 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 ... aspects of the operational business comply with GXP legal and Regulatory Requirements and the company's Animal Health Policies and Procedures.Job… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director , Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 ... 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)
- …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 ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… 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 ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… 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 ... Job DescriptionThe Executive Director , Vaccines Communications is responsible for leading, developing...Vaccines Communications is responsible for leading, developing and executing US and global communications strategies and programs that support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads US FDA/EU EMA interactions with support from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US /EU regulatory ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with… 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 ... while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field...managing the execution of National & Regional Conventions for US brands & Regional Marketing team. This position will… more
- S&P Global (New York, NY)
- …Role:** **Grade Level (for internal use):** 12 **_The_** **_Role:_** **_Regional Commercial Associate Director - Regulatory Compliance_** **The Team:** This ... to persons with indefinite right to work in the United States . **Return to Work:** Have you...actively support your return to the workplace. **Compensation/Benefits** **Information ( US Applicants Only):** S&P Global states that… more
- Insight Global (Florham Park, NJ)
- Job Description Insight Global is seeking an Associate Director of Regulatory Affairs to join the one of our pharmaceutical clients in Florham Park, NJ. This ... . Skills and Requirements 7+ years of experience with regulatory strategy in the US Background heavily focused on therapeutics Knowledge of Phase 1,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …meet its goals and objectives. This group also represents Gilead's commercial activities to US regulatory agencies. You will manage the commercial regulatory ... Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience with ex- US … more
- Organon & Co. (Jersey City, NJ)
- …or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist ( Associate Director ) is responsible for Regulatory ... are position specific. Please, no phone calls or emails. **Applicable to United States Positions Only:** Under various US state laws, Organon is required to… more
- Organon & Co. (Jersey City, NJ)
- … in Organon Regulatory Chemistry, Manufacturing and Controls New Products, the Associate Principal Scientist ( Associate Director ) is responsible for ... products in accordance with global regulations, guidance's and defined regulatory strategies. These products may be internal or acquired...phone calls or emails. **Applicable to United States Positions Only:** Under various US state… more
- System One (Florham Park, NJ)
- …regions, and provide insights to the Senior Director and Associate Director . + Contribute to managing regulatory risks and opportunities related to QOL ... (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to...internationally + Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …with significant unmet medical needs in North American markets. In the United States , MTPA launched rare disease treatments including RADICAVA(R) (edaravone) ... . Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a US subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in...evidence, and creating hope for all facing illness. The Associate Director , Data Management is responsible for… more
