- Sanofi Group (Morristown, NJ)
- …for submission to regulatory agencies, including but not limited to the FDA and EMA + Prepare abstracts, posters and manuscripts for external presentation and/or ... potential drug-drug interactions, quantifying benefit-risk relationships, and contributing to regulatory submissions and interactions from first-in-human studies through life-cycle… more
- Penn Medicine (Cherry Hill, NJ)
- … Regulatory : . Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... to emergency/code situations. . CCA MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Penn Medicine (Woodbury Heights, NJ)
- …/ Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... to emergency/code situations. + CCA CSAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …external partners, and quality systems for ensuring compliance with regulatory requirements and expectations, standards, industry trends, and regulatory ... company policies and procedures. The role involves supporting readiness for regulatory inspection and collaborating across the regional organization to participate… more
- Penn Medicine (Somers Point, NJ)
- …/ Regulatory Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... geriatric. Clinical Care Associates (CCA) CSAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads… more
- Organon & Co. (Jersey City, NJ)
- …all levels of our business. + Maintain a vigilant watch over the regulatory environment specific to Primary Market Research and Data Analytics, alerting management ... and senior executives of emerging regulatory changes that may impact the business processes, make...State Privacy Laws, LGPD and other similar regulations; and FDA requirements). + Strong understanding of the evolving AI… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …the overall medical strategy taking into consideration the medical, scientific, regulatory and commercial issues and opportunities for assigned portfolio products. ... team evaluating submitted proposals. + Contributes to Medical aspects of Regulatory issues related to development compounds or marketed products including labeling… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …of a Global team implementing and maintaining a PV system that is regulatory compliant and will also support the development, registration and commercialization of ... and leadership support/guidance to the Junior staff on regional regulatory authorities and PV related issues + Collaborate with...Reports (PADERS) and other aggregate safety reports to the FDA . + Request 356h form and relevant PADER contributions… more
- Sumitomo Pharma (Trenton, NJ)
- …collection systems and final reports in compliance with appropriate scientific/ regulatory /medical standards + Contributes to developing clinical components of ... BLA/NDAs, sNDAs, MAAs and other regulatory filing documents + Contributes to company responses to...travel **Key Core Competencies** + Knowledge and understanding of FDA , GCP, and ICH regulations and guidance + Thorough… more
- Ascendis Pharma (Princeton, NJ)
- …launch of an investigational treatment for hypoparathyroidism currently under review by the FDA . This role requires the ability to be both strategic and tactical, ... to renewal and termination. Ensure compliance with company policies, regulatory requirements, and contractual obligations. Expectations in this role include… more