- Boehringer Ingelheim (Ridgefield, CT)
- …will also provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance as well as act as primary company ... liaison with the US Food and Drug Administration. This role will primarily be focused in the therapeutic area of Cardio Renal Metabolic. (CRM). + Provide analysis,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the assigned therapeutic area from the global regulatory, scientific, pharmaceutical, pharmacovigilance , market access and commercial perspective as well as engage ... in at least one TA and a broad range of global regulatory and drug development topics. + Seamlessly interact and collaborate cross functionally at all levels of… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... and up to 2 studies in late development) + Seamless transition of drug candidates from research to early clinical development + Effective integration of in-licensed… more
- Merck (Rahway, NJ)
- …products with a focus on auto-injectors, pre-filled syringes and other innovative drug delivery systems. The ideal candidate will have a strong background and ... play a key leadership role in ensuring regulatory compliance, patient safety , and continuous improvement of device complaint quality systems. **Key… more
- AbbVie (Mettawa, IL)
- …communications, training, and clinical value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). ... the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements + Participates… more
- Edgewell Personal Care (Allendale, NJ)
- …and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance . + Proven ability to communicate, influence and ... Canada, TGA, and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements....of the consumer products industry. + Experience with OTC drug regulations for FDA, Health Canada, and TGA. Medical… more
- BeOne Medicines (Emeryville, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more
- Sanofi Group (Morristown, NJ)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... development scientists, in the project in collaboration with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver… more