- Bristol Myers Squibb (Madison, NJ)
- …strategies. + Support Global Product Teams (GPT) on clinical development and regulatory activities through robust evidence generation to optimize patient access. + ... + Strong knowledge of pharmaceutical development and product promotional guidelines (eg FDA Consistent with Label guidance, FDAMA 114). + Limited domestic and… more
- Parexel (Trenton, NJ)
- …+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be fluent in English and in ... command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical… more
- Actalent (Parsippany Troy Hills, NJ)
- …Specialist III, you will manage change controls, ensuring compliance with regulatory requirements, and oversee CMO-related activities. You will maintain programs and ... controls and oversee CMO-related activities. + Ensure compliance with applicable regulatory requirements. + Maintain programs to ensure product quality and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …laboratory information management systems (LIMS) or bioinformatics platforms. + Familiarity with regulatory standards for medical software (GMP, GxP, FDA , IEC ... ensuring traceability throughout the project lifecycle and alignment with regulatory , compliance, and quality standards. + Contribute to solution design… more
- Bristol Myers Squibb (Summit, NJ)
- …+ BS degree or equivalent experience + Minimum 5 years of experience in FDA -regulated industry with at least 2 years of recent hands-on CSV and implementation ... with customers to ensure all expectations are being met. Regulatory Responsibilities + Ensure equipment, facilities and programs are...as departmental lead and SME in both internal and regulatory audits. The starting compensation for this job is… more
- Actalent (Parsippany Troy Hills, NJ)
- …and coordinating with cross-functional departments to ensure compliance with regulatory requirements. This role involves maintaining programs to ensure high-quality ... Organizations (CMOs). + Perform activities to ensure compliance with regulatory requirements. + Maintain programs and processes for high-quality products… more
- Penn Medicine (Somers Point, NJ)
- …/ Regulatory : . Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... . Flexible and readily adopts new processes and engages in practice operation changes. Access Center Responsibilities (if appropriate): . Coordinates clinical and administrative aspects of the new patient scheduling encounter. . Perform within the expected… more
- Norstella (Trenton, NJ)
- …research and industry trend analysis, including competitive positioning, regulatory changes, domain-specific insights, and opportunities + Drive innovation ... initiatives + Deep domain expertise in MoAs, therapeutic positioning, regulatory changes, and repurposing opportunities + Demonstrated ability to manage… more
- Hormel Foods (Bedminster, NJ)
- …of regulatory changes and ensure R&D operations remain compliant (USDA/ FDA ). + Determine feasibility of project objectives, timelines, and deliverables, and ... detail, follow through and decision-making skills + Experience in government regulatory requirements. + Strong communication (both written and verbal), negotiating… more
- J&J Family of Companies (Titusville, NJ)
- …of responsibility * Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies ... robotics and automation. * Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP) **Qualifications:**… more