- Actalent (Piscataway, NJ)
- Job Title: Quality Assurance and Regulatory Affairs SpecialistJob Description As a Quality Assurance and Regulatory Affairs Specialist, ... as a team, and transcending what is possible. + Support Regulatory Affairs and Quality Assurance management as needed. + Perform all other duties as… more
- Integra LifeSciences (Princeton, NJ)
- …manufacturing. **Cross-Functional Collaboration:** + Collaborate closely with cross-functional teams (eg, quality assurance , regulatory affairs , R&D, ... projects, and work cross-functionally. + Detail-oriented with a commitment to maintaining high- quality standards and regulatory compliance. + Experience with … more
- J&J Family of Companies (Raritan, NJ)
- …continuous improvement. **Stakeholder Collaboration:** + Work closely with cross-functional teams, including Quality Assurance , Regulatory Affairs , and ... compliance frameworks. **Data Management:** + Establish protocols for data integrity, quality assurance , and validation to support compliance objectives. +… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational...quality assurance , etc.) in pharmaceutical or healthcare… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **JOB SUMMARY** The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to ... SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient… more
- Bausch + Lomb (Trenton, NJ)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance , Pharmacovigilance/GPSS ... ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in relevant training programs. + Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance. + Keep abreast of ... and that technology-related audits are conducted. + Oversee and guide quality assurance processes related to project specifications, ensuring standard… more
- J&J Family of Companies (Titusville, NJ)
- …regulatory filings. Team matrix interactions include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical ... supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs , clinical pharmacology, clinical… more
- General Motors (Trenton, NJ)
- …Regulatory Lead, you will report to the Head of AV Safety Strategy and Assurance and lead regulatory efforts related to AV behavior, including traffic law ... compliance and performance standards. You'll collaborate with Legal, Government Affairs , and regulatory experts to ensure compliance, influence future… more
- J&J Family of Companies (Titusville, NJ)
- …Clinical Team. Team matrix interactions may include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical supplies ... unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics,...team and be responsible for timely completion, content and quality of key documents eg clinical development plans, protocol… more
- Catalent Pharma Solutions (Somerset, NJ)
- …systems and sites. **EDUCATION AND** **EXPERIENCE** : Requires a Bachelor's degree in Drug Regulatory Affairs and 3 years of experience in job offered or 3 ... and IT teams acting as an expert on quality , regulatory , and compliance resource, bringing forth...new world-class systems and leverage existing systems for the assurance of GMP Manufacturing to help support the growth… more
- Terumo Medical Corporation (Somerset, NJ)
- …of customer complaints (ie, adverse events, product performance reports, etc.) to Quality Assurance (QA), and by ensuring all promotional messaging (ie, ... NJ, US, 08873 Company: Terumo Medical Corporation Department: Medical Affairs Operations Terumo Medical Corporation (TMC) develops, manufactures, and markets… more