- Novo Nordisk Inc. (Plainsboro, NJ)
- …- Submissions supports the development of submission plans created for regulatory submissions . This individual will be responsible for supporting the ... preparation, delivery, archiving and tracking of regulatory submissions to FDA and Health Canada.... Operations and works cross-functionally with internal departments on Regulatory Affairs related issues. Essential Functions With… more
- J&J Family of Companies (Titusville, NJ)
- …Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional **All Job ... responsible for the operational management and delivery of global clinical trial regulatory submissions . + Create and handle dossier plans/submission packages in… more
- The Hartz Mountain Corporation (Secaucus, NJ)
- MANAGER , REGULATORY AFFAIRS Secaucus, NJ (http://maps.google.com/maps?q=200+Plaza+Drive+Secaucus+NJ+USA+07094) Job Type Full-time Description ** Manager , ... seeking a Manager with extensive experience in the pesticide industry to join our Regulatory Affairs team. In this role, you will oversee the regulatory … more
- Nestle (Bridgewater, NJ)
- …for patients and consumers. **Position Summary:** Reporting to the Head of Global Regulatory Affairs Pharma, the Regulatory Affairs Advertising, ... ensuring alignment with the overall company strategy. In collaboration with Global Regulatory Affairs leads and cross functional teams, this individual will… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- ThermoFisher Scientific (Cranbury, NJ)
- …food is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs , you will play a crucial role in interpreting ... for global requirements and desired marketing claims. + Author and/or review regulatory submissions , specifically device master files, regulatory support… more
- Meta (New York, NY)
- **Summary:** We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a ... wrist wearables, and other innovative devices. **Required Skills:** Medical Devices, Regulatory Affairs Specialist Responsibilities: 1. Interact directly with… more
- J&J Family of Companies (Titusville, NJ)
- …Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** People Leader **All ... way. Learn more at https://www.jnj.com/innovative-medicine We are seeking **Senior Manager , RA Submissions ** to be located Raritan,...+ Bachelor's Degree or higher in Life Sciences, Pharmacy, Regulatory Affairs , or a related field. +… more
- Mount Sinai Health System (New York, NY)
- …or health care policy. + A minimum of 5 years of research experience in Regulatory Affairs , Clinical Affairs or Quality Assurance with knowledge of Phase ... event forms, etc. + Collaborates with the Clinical Trials Manager in developing and ensuring clinical trial regulatory...submissions as required. + Collaborates with the Financial Manager on the development of the study budget (as… more
- J&J Family of Companies (Raritan, NJ)
- …Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** People Leader **All ... Johnson Innovative Medicine R&D is recruiting for a Senior Manager , Strategy, Portfolio and Operations. This position is a...illustrate the benefits realized and the impact on Global Regulatory Affairs (GRA) goals and objectives. +… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …development and ability to provide programming support and leadership for BLA and other regulatory submissions . + Experience in working on a submission to ... The Senior Manager Statistical Programming for Medical Affairs ...of statistical deliverables from a single study through to regulatory approval, product launch, and annual reports. The Senior… more
- Kelly Services (Raritan, NJ)
- …creation of project value propositions as needed. + Provides strong connectivity with Medical Affairs , R&D, Regulatory Affairs , and Clinical Affairs ... **Project Manager , Scientific Operations Technical & Medical Writing** The...management activities associated with the execution of medical & regulatory documentation including Clinical Evaluations, Literature Reviews, and Periodic… more
- J&J Family of Companies (Raritan, NJ)
- …Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional **All Job ... Product Lifecycle Management (PLM), Product Packaging Design, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Standard… more
- Eliassen Group (Trenton, NJ)
- …risk management, and communication across all stakeholders. * Coordinate with Regulatory Affairs to ensure documentation and submission readiness for ... **Project Manager , Med Device, R&D PMO, Design Changes** **Anywhere**...and industry regulatory standards. * Exposure to Regulatory submissions and Operations/manufacturing interfaces. * Background… more
- Sumitomo Pharma (Trenton, NJ)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... software + Ability to evaluate and write case reports and prepare regulatory submissions + Analytical thinking and attention to detail + Communication skills for… more
- Mount Sinai Health System (New York, NY)
- …The Regulatory Project Coordinator will be responsible for supporting the regulatory affairs team in managing and coordinating regulatory projects. ... consent forms, site-specificregulatory packets). + Collect, organize, and assemble regulatory submissions , including FDA 1572 Forms, financial disclosure… more
