- Astrix Technology (Boston, MA)
- …Collaboration: Work closely with internal teams such as Clinical Development, Regulatory Affairs , and Commercial to provide medical insights that ... decisions. + Compliance and Reporting: Ensure all activities comply with regulatory standards and company policies, and accurately document interactions and insights… more
- ThermoFisher Scientific (Greenville, NC)
- …Indication Development Teams and cross-functional partners, including Trial Operations, medical affairs , regulatory affairs , global patient advocacy, and ... (GloSAM). Ensure alignment of recruitment strategies with study protocols and regulatory requirements. Provide coaching and mentoring to other team members Provide… more
- Curia (Albuquerque, NM)
- …deviations, and CAPA + Demonstrated understanding of laboratory, manufacturing, packaging, regulatory affairs , compliance, and quality assurance requirements for ... role provides clear guidance on quality requirements consistent with cGMPs, regulatory expectations, and industry best practices, ensuring objectives are met within… more
- Lilly (Indianapolis, IN)
- …"patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for ... clinical experience, the Cardiovascular/Cardiometabolic Business Unit - Global Medical Affairs Clinical Research Physician (CRP) Senior/Executive Director is an… more
- Stryker (Irvine, CA)
- …by building strong relationships across technical teams and business units-including Regulatory Affairs , Quality, Marketing, Clinical, Operations, and Finance-to ... teams through risk management (eg, FMEA), and reviewing or delegating approval of regulatory documentation in compliance with FDA 21 CFR Part 820 and ISO 13485.… more
- Catalent Pharma Solutions (San Diego, CA)
- …with at least five (5) years' of experience in Quality Assurance or Regulatory Affairs with progressive responsibilities; + Experience in managing people, ... Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. Lead the development… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …This role works in close partnership with R&D, Enterprise Security, Quality, Regulatory Affairs , Legal, business leaders and functional authorities at corporate, ... teams. Oversee delivery of all required product security quality and regulatory documentation associated with product launches in Dispensing. Champion initiatives… more
- AbbVie (North Chicago, IL)
- …biochemistry), bioengineering, biomedical engineering, public health, clinical research, regulatory affairs , biomedical sciences, nursing, health sciences, ... team ensures that clinical research and operations consistently meet regulatory requirements, internal standards, and ethical guidelines, thereby protecting patient… more
- BeOne Medicines (Emeryville, CA)
- …development. This role partners closely with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs , and Clinical Development to ensure robust study ... design, insightful data analysis, and timely support for global regulatory submissions. Deep expertise in PK modeling, including non-compartmental and population PK… more
- AbbVie (North Chicago, IL)
- …RDQA) organization, working collaboratively and strategically with colleagues in R&D, Operations, Regulatory Affairs , Medical Safety and more to develop and ... technical information is accurate and in compliance with quality and regulatory requirements. + Prepare information for communication and knowledge sharing using… more