- Sanofi Group (Morristown, NJ)
- …data submissions. + Recognized authority in business process optimization in regulatory affairs . + Expert understanding of capability-based planning, agile ... capability roadmaps with enterprise impact, serve as a strategic bridge between regulatory SMEs, business process owners, and digital product teams, and lead the… more
- J&J Family of Companies (New Brunswick, NJ)
- …of degree is required. Advanced degree in management, EHS technical field or regulatory affairs , preferred. **Other:** An advanced degree MS or MBA preferred. ... Inclusive Leadership, Leadership, People Performance Management, Quality Assurance (QA), Regulatory Compliance, Relationship Building, Risk Management, Safety-Oriented, Strategic Thinking,… more
- J&J Family of Companies (Titusville, NJ)
- …for product hierarchies, nomenclature, and lifecycle transitions. + Partner with Regulatory Affairs , Clinical Operations, Supply Chain, and Commercial to ... & Supply (PTDS), and connecting seamlessly with clinical trial and regulatory data. This lifecycle mastering ensures continuity into commercial brand naming… more
- NRG Energy, Inc. (Princeton, NJ)
- …or internal NRG data, create reports for internal distribution and collaborate with the Regulatory Affairs and Government Affairs teams to help formulate ... and X. **Job Summary:** As a member of the Regulatory Compliance NERC Team, the Director NERC Compliance provides...experience. + Proven ability to stay current with evolving regulatory changes, NERC O&P standards, and guidelines. + Demonstrated… more
- Sanofi Group (Morristown, NJ)
- …, etc.) + Partners effectively with relevant departments (eg Commercial, Clinical Development, Regulatory Affairs , Medical Affairs , HEOR, etc.) to influence ... (HEVA, GMAX CoE, Affiliates ) and beyond (Commercial, Clinical, Medical, Regulatory , Biostatistics, etc.) to build successful access and pricing strategies, plan… more
- J&J Family of Companies (Titusville, NJ)
- …Mindset, Drug Discovery Development, Industry Analysis, Innovation, Market Research, Regulatory Affairs Management, Research Ethics, Scientific Evaluation, ... and interpret clinical trial data, provide input into clinical study and regulatory communications and reports, and contribute to clinical development plans and… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …will require extensive interaction with Portfolio, R&D, Business Development, and Regulatory Affairs . **Responsibilities:** + Manage patent litigations in North ... internal stakeholders on all aspects of pharmaceutical patent and regulatory law, including exclusivity issues and launch scenarios **Qualifications** **Educational… more
- Taiho Oncology (Princeton, NJ)
- …guidelines. + Partners with the Clinical Development, Product Development, Regulatory Affairs , Commercial, Legal and Finance departments. Education/Certification ... Employee Value Proposition: This role provides the opportunity to lead Medical Affairs (MA) activities across therapeutic areas for both pipeline and marketed… more
- Sumitomo Pharma (Trenton, NJ)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health.… more
- Organon & Co. (Jersey City, NJ)
- …of industry experience in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... three years of experience in project management. + Proficient with MS Project, MS Timeline, and all Office products. + A working understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management. + Worked… more