- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The Position The Specialist , Regulatory Operations - Submissions supports the development of submission plans ... created for regulatory submissions . This individual will be responsible...FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal… more
- Bristol Myers Squibb (Princeton, NJ)
- …Review Editor (PRE) of the Specialist level in US Commercial Regulatory Affairs Operations (CRA Ops) supports the Promotional Review Process (PReP) ... label updates including providing strategy for Subpart Binder submission. + Work with CRA Operations Submissions team as needed to create and submit 2253 … more
- Nestle (Bridgewater, NJ)
- … dossier events and requirements to drive the execution of submissions . The Regulatory Operations Specialist must have Regulatory Operations ... and nutrition for patients and consumers. **Position Summary:** The Regulatory Operations Specialist will be... regulatory landscape focused on regulatory submissions requirements, potential regulatory operations … more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …to ensure regulatory compliance. + Prepare, submit, and maintain global regulatory submissions and registrations. + Write and update standard operating ... **Job Description Summary** The Staff RA Specialist will represent Regulatory Affairs within...timely manner. Act as liaison with FDA regarding product submissions . + Assess US regulatory requirements for… more
- Cardinal Health (Trenton, NJ)
- …programs and regulatory submissions . **_Job Summary_** The Senior Regulatory Specialist , Data Management & Governance for Medical Devices plays a ... applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process… more
- Kelly Services (Bridgewater, NJ)
- …Adobe Acrobat is required. + Knowledge of standards and regulations relating to submissions and regulatory approval of device products. + Knowledge of product ... **Global Labeling Lead Specialist ** Kelly(R) Science & Clinical is seeking a...support + Provides RA artwork support for health authority submissions ; provides before/after artworks, redlined PDFs, etc. + Monitors… more
- Penn Medicine (Plainsboro, NJ)
- …State Board of Pharmacy Rules and Regulations. Responsible for assisting pharmacy operations management focusing on technician workflow and serving as a technical ... automation systems. This individual utilizes system reports to monitor regulatory compliance (eg resolution of controlled substance discrepancies, unit inspections)… more
- TD Bank (Mount Laurel, NJ)
- …ongoing supervision. Teammates interact directly and independently with auditors and regulatory agencies and provides approval for document submissions to ... to make a tangible impact - both in day-to-day operations and in the design of a future-focused compliance...Compliance Audit and Exam Management manages internal audits and regulatory exams of the Compliance function, tracks remediation efforts… more
- Sanofi Group (Morristown, NJ)
- …in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim ... cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations . + Maintain awareness of current clinical… more
