- Terumo Medical Corporation (Somerset, NJ)
- …15%. **Job Details/Responsibilities** + Ensure full compliance with US Food and Drug Administration ( FDA ) regulations, international regulatory requirements, ... across US and international markets and ensures compliance with FDA , Terumo, and global regulatory standards. The Senior Labeling Specialist II functions as an… more
- Sanofi Group (Morristown, NJ)
- … interactions, quantifying benefit-risk relationships, and contributing to regulatory submissions and interactions from first-in-human studies through life-cycle ... scoping and planning. + Good knowledge of industry best practices, global regulatory , processes, standards of drug development. **Demonstrate the following… more
- Sanofi Group (Morristown, NJ)
- …+ Contribute to the clinical part of Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc.) and answer to questions from health ... leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy… more
- Norstella (Trenton, NJ)
- …life-saving therapies. Norstella supports pharmaceutical and biotech companies across the full drug development lifecycle - from pipeline to patient. Our mission is ... strategic, clinical, and commercial decision-making. We help our clients: + Accelerate the drug development cycle + Assess competition and bring the right drugs to… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and ... in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role...patients. **Job Description** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream… more
- Sanofi Group (Morristown, NJ)
- …clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA) and answers to questions from health ... + Clinical trial or pharmaceutical experience in ophthalmology + Knowledge of drug development, ocular gene therapy, regulatory strategy + Good networking… more
- Stryker (Mahwah, NJ)
- …knowledge of MIM processes and tooling + Experience with process validation and regulatory compliance ( FDA , ISO 13485) Health benefits include: Medical and ... multiple manufacturing sites and collaborate closely with R&D, Manufacturing, Quality, Regulatory , and Supply Chain to deliver projects that meet medical device… more
- Stryker (Mahwah, NJ)
- …with Quality, Regulatory , and Advanced Technology to ensure compliance with FDA , ISO, and internal standards. + Identify and implement NPI best practices across ... work across multiple Stryker sites and collaborate with R&D, Quality, Regulatory , and Operations to ensure manufacturability, scalability, compliance, and on-time… more
- Ascendis Pharma (Princeton, NJ)
- …(Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA safety regulations, ICH ... our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially… more
- Colgate-Palmolive (Piscataway, NJ)
- …+ Knowledge of Regulatory environment across the globe + Knowledge of ICH/ FDA guidelines for stability and testing of new drug products **Compensation and ... high-quality commercialization. + Maintain all required documentation under **GMP/GLP** per FDA /ICH guidelines as required. + Documentation may include R&D project… more