- Lilly (Indianapolis, IN)
- …management experience. + Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. **Additional Information:** + Available ... owners to obtain potential risks associated with document changes, including regulatory non-compliance, process interruptions, or misalignment between global … more
- J&J Family of Companies (Titusville, NJ)
- …clinical study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are ... matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs, finance, legal, quality assurance, quality… more
- Takeda Pharmaceuticals (Boston, MA)
- …area knowledge relevant to mechanisms of action of compounds in remit + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in designated ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Pfizer (New York, NY)
- …working collaboratively with Oncology Early-and-Late Clinical Development, CMO, Safety, Oncology Regulatory Strategy, Global Value and Access and other functions ... the Program Strategy Management Group Lead. + The Program Lead will support Global and/or US Medical Franchises, l by providing strategic partnership and operational… more
- Howmet Aerospace (Cleveland, OH)
- …customer and regulatory requirements. Key Responsibilities: + Develop and implement global supplier quality standards aligned with ISO 9001 and IATF 16949 to ... metallurgical processes including casting. + Experience managing remote or global teams. + Knowledge of Regulatory landscape...remote or global teams. + Knowledge of Regulatory landscape related to transportation and automotive products. +… more
- Bristol Myers Squibb (Devens, MA)
- …training programs and implementing contamination control strategies. + Strong knowledge of global regulatory requirements for aseptic processing and cell therapy ... (APQ) for CAR-T manufacturing operators, including periodic reviews. + **Compliance & Regulatory Expertise** + Ensure adherence to GMP, global health authority… more
- Bristol Myers Squibb (San Diego, CA)
- …manufacturing, quality, supply chain, and commercial functions. + Advise on global regulatory matters relevant to radiopharmaceuticals, including FDA regulations ... supply, manufacturing, licensing, collaboration, and research agreements. + Monitor evolving global legal, regulatory , and enforcement developments relevant to… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …to ensure HF validation activities are thorough, risk-retiring, and aligned with global regulatory requirements. + Update and maintain **risk documentation and ... usability testing** , and **risk documentation** . + Strong understanding of ** global regulatory HF requirements** (eg, FDA, IEC 62366-1, EU MDR). + Ability to… more
- JPMorgan Chase (Jersey City, NJ)
- …a related field + Experience driving innovation and operational efficiency in global organizations + Familiarity with regulatory compliance requirements and ... future with your strategic vision and influence. As a Product Director in Global Security, you lead innovation through the development of products and features that… more
- ThermoFisher Scientific (Juneau, AK)
- …trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; good understanding of a regulatory ... members to producing compliant deliverables + Strong understanding of global /regional/national country requirements/ regulatory affairs procedures for clinical… more