- System One (Princeton, NJ)
- …experiments, analyze data, draw conclusions, and recommend actions + Basic knowledge of FDA regulatory requirements for OTC products + Ability to prioritize and ... policies for working in the laboratory designated for the development of FDA regulated products + Assist in maintaining laboratory compliance including equipment… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …+ The Regulatory Affairs Specialist, assists in the management of regulatory submissions to ( FDA ) and other Health Authorities, as required, within ... Description: The Regulatory Affairs Specialist assists in the preparation, review... submissions such to the Food and Drug Administration ( FDA ) and other Health Authorities, as required, within company… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …documentation and product labeling in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions, EU technical files, and other ... product review and approval. + Point of contact for FDA , EU notified bodies, and other regulatory ...for FDA , EU notified bodies, and other regulatory agencies on submissions and other issues. + Independently… more
- Sanofi Group (Morristown, NJ)
- …on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...in helping our teams accelerate progress. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for… more
- Actalent (Neptune City, NJ)
- …Nurse (OCN). Additional Skills & Qualifications + BSN preferred. + Knowledge of FDA regulatory , IND reporting, and proficiency in Microsoft or similar Office ... + Act as a liaison between principal investigators and sub-investigators on regulatory issues and protocol changes. + Collaborate with the principal investigator to… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …performance of all products. Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world as needed + ... ideation, concept development, product verification, and validation, legal and regulatory compliance, demonstration of product value, and stakeholder education. In… more
- Sanofi Group (Morristown, NJ)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research...asset and indication strategy meeting, as well as in FDA meetings on invitation. + The Senior COA Lead… more
- Ascendis Pharma (Princeton, NJ)
- …appropriate pre-approval and/or disease education communications + Serve as the company's regulatory liaison to the FDA 's Advertising and Promotional Labeling ... working with prescription drug, biologic, and/or combination products; experience managing major regulatory filing(s) to the FDA Office of Prescription Drug… more
- Bayer (NJ)
- …timely and accurate implementation of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling ... and analyzes and evaluates requests for new or revised labeling initiated by FDA or Bayer HealthCare Pharmaceuticals and manages action required to implement; +… more
- Sumitomo Pharma (Trenton, NJ)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA… more