- Cytel (Trenton, NJ)
- …model-informed drug development), to provide strategic advice to define optimal regulatory , clinical and/or market access pathways and promote faster patient access ... recognized thought leader and strategic advisor in the areas of optimal regulatory , clinical development and/or market access pathways and quantitative strategies to… more
- Astrix Technology (Essex County, NJ)
- …initiatives across product development, method validation, risk assessment, and regulatory compliance. **Key Responsibilities:** + Lead the design and execution ... + Contribute to the creation of technical documentation to support regulatory submissions, global market entry, and ongoing compliance. + Ensure scientific… more
- J&J Family of Companies (Raritan, NJ)
- … regulatory inspections, and health authority questions. **Qualifications:** + PhD in Chemical Engineering, Microbiology, Cell Biology, or related with 10-12 ... aimed at reducing non-conforming product rates, through projects that may/may not require regulatory approval + Provide technical support to regulatory filings,… more
- Taiho Oncology (Princeton, NJ)
- …enhance scientific dialogue and engagement. The individual ensures compliance with regulatory policies, oversees vendor and budget management, and leads strategic ... to achieving corporate objectives while maintaining the highest ethical, regulatory , and scientific standards. Performance Objectives: + Lead the development… more
- J&J Family of Companies (Raritan, NJ)
- …internally and externally. In this role, you will partner with R&D, Quality, and Regulatory to ensure processes meet the needs of today and tomorrow. The Principal ... + Contribution, review and approval of the product technical and regulatory documents (eg, protocols, reports, filings, criticality analysis, control strategies,… more
- System One (Florham Park, NJ)
- …processes, and compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to medical inquires, disseminate scientific ... report AEs and PQCs. Minimum Job Requirements + Advanced scientific degree (such as PharmD, PhD , MD, RN or equivalent) is preferred. + Minimum three (3) years in the… more
- J&J Family of Companies (Raritan, NJ)
- …with the Compound Development Team (CDTL) and project management, global regulatory affairs, clinical pharmacology, health economics, and the disease area leader ... evaluation and develops the strategy and the content for regulatory documents. + Works with senior clinical staff, establishes...- External** + An MD is required; Advanced degree ( PhD ) is a plus. + A minimum of 2… more
- Organon & Co. (Jersey City, NJ)
- …objectives. + Collaborate with cross-functional teams, including clinical development, regulatory affairs, marketing and sales, to ensure alignment of medical ... medical expertise and strategic guidance to support product development, regulatory submissions, and commercialization efforts. + Support business development… more
- Abbott (Princeton, NJ)
- …maximize execution of strategic initiatives. . Ensures team member adherence to regulatory and compliance guidelines in all aspects of scientific dissemination of ... information** **Cross-functional** **collaboration/interaction** **with Clinical Affairs, R&D, Regulatory , Quality, OEC, Legal, Global Marketing & Commercial teams**… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …for assigned areas. Knowledge and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay abreast of the latest ... and real-world evidence, US and global commercial teams, market access, and regulatory affairs, to ensure integrated global strategies and cohesive medical affairs… more