- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...and device development process, laws, regulations, and guidelines from FDA , EMA, PMDA, ICH, etc. + General knowledge of… more
- Bausch + Lomb (Trenton, NJ)
- …solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies. + Monitors FDA and FTC ... abreast of market promotional and advertising strategies. + Provide regulatory support as needed for FDA warning...+ Provide regulatory support as needed for FDA warning and untitled letters, FTC letters, and direct… more
- J&J Family of Companies (Titusville, NJ)
- …their opportunities and limitations. + Knowledge of endpoint validation frameworks and regulatory requirements (eg, FDA /EMA) is highly desirable. + Proficiency ... with the Neuroscience Therapeutic Area, Clinical Development, Quantitative Sciences, Regulatory and Patient Reported Outcomes. **Key Responsibilities:** + Design,… more
- Ascendis Pharma (Princeton, NJ)
- …via the Submission Project Teams. + Thorough working knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA , EMA, ICH, ... for employees to grow and develop their skills. The Regulatory Project Manager will be an integral part of...Project Manager will be an integral part of Global Regulatory Affairs, providing project management leadership to key global… more
- Mondelez International (East Hanover, NJ)
- …for your respective categories and geographical area using your Scientific and Regulatory expertise. You advocate for our regulatory and scientific positions ... and government agencies and guide the execution of policies and scientific and regulatory programs. **How you will contribute** You will monitor the external … more
- Parexel (Trenton, NJ)
- …and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master ... drug development-we help shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding… more
- Sumitomo Pharma (Trenton, NJ)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/She...to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... be critical in helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with other key functional… more
- Ascendis Pharma (Princeton, NJ)
- …TransCon programs, competitive landscape, new therapies, clinical trends, and newly issued regulatory rules and FDA guidance to promptly identify any potential ... assets for assigned product(s), and collaborate with Commercial, Legal, and Regulatory for development and review of Labeling, advertising, and promotional… more
- Cytel (Trenton, NJ)
- …Medidata Rave, Oracle Inform, Veeva, or similar). + Excellent understanding of ICH-GCP, FDA , EMA, and other global regulatory guidelines. + Strong attention to ... individual brings advanced knowledge of medical terminology, clinical trial processes, regulatory requirements, and coding best practices. The Senior Medical Coder… more