- 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
- 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
- Merck (West Point, PA)
- …AS&T and QC teams. + Provide leadership and expertise for preparation of regulatory submissions , inspection readiness, and support health authority inspections - ... **Job Description** **Purpose of Role:** The Site Analytical Sciences senior Specialist role is responsible for supporting Analytical Procedure Life Cycle through… more
- Merck (West Point, PA)
- …workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical ... clinical supplies follow current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions . Areas of focus of this position… 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
