- Organon & Co. (Jersey City, NJ)
- …developmental compounds or marketed products throughout the entire life cycle of the drug . + Represent Global Regulatory Affairs within our company's internal ... **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director,...meetings with FDA or EMA at any phase of drug development. Lead cross-functional efforts to prepare and lead… more
- Merck (Rahway, NJ)
- …BS in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. + MS with 10+ years ... **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in delivering new medical advancements to patients around the world.… more
- Bristol Myers Squibb (Princeton, NJ)
- …studies including FIH, and strategies in 14C human ADME studies. + Understanding of regulatory requirements in the areas of drug metabolism, drug - drug ... areas: + Experience in drug development, authoring drug metabolism reports for regulatory submissions. +... development, authoring drug metabolism reports for regulatory submissions. + In-depth understanding of the principles, theories… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription … more
- Merck (Rahway, NJ)
- …will also coach their staff in the concepts, methods, and nuances of, drug development, project management, and regulatory operations. + Operates well in ... experience in pharmaceutical/healthcare/consumer care industry + Leading cross-functional teams in regulatory affairs or other drug development functions +… more
- Merck (Rahway, NJ)
- …model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams.Collaborate with other functional areas, as well ... of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. + Educational background in… more
- J&J Family of Companies (Titusville, NJ)
- …/ DETAILED DUTIES:** + Assists Regulatory Affairs in the development of drug regulatory strategies + Helps explore and evaluate new product ideas to ... for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include project management, finance, legal, quality… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … drug labeling. + Significant experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, ... Strong track record of successes working and negotiating with regulatory authorities. + Global prescription drug label...negotiating with regulatory authorities. + Global prescription drug label experience, US, EU, and potentially more. +… more
- J&J Family of Companies (Raritan, NJ)
- …clinical team members + Assists Regulatory Affairs in the development of drug regulatory strategies + Participate on and may lead cross-functional teams for ... clinical study reports and supports preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with colleagues… more
- Bristol Myers Squibb (Madison, NJ)
- …clinical development leader; with greater than 10 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong ... organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution,… more