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Fermentation, Scientific and Regulatory Affairs
Expert is dedicated to commercializing novel ingredients for health and sustainability Proficient in human pathology, plant biology, synthetic biology, and fermentation technology. Her specialties include Product Innovation and Formulation, CPG Application Testing COGS and Process Improvement, Food Science, Safety and…
Scientific, Clinical, Medical, and Regulatory Affairs
Expert is a senior executive and a global biomedical leader with expertise in all facets of basic, pre-clinical, clinical research, and regulatory science for drug, biologic, therapy, vaccine, and medical device development. Expert is a leader in strategic planning and…
International Affairs and Security Policy
Experienced international affairs and security policy expert. Skilled in Public Affairs, Government, Crisis Communications, Media Relations, and Public Policy. Deep expertise in digital, data and technology and a track record of successfully delivering complex digital transformation programmes. SKILLS: Change management:…
Product Compliance, Regulatory Affairs, Safety EMI EMC, ENV, RoHS Testing and Certifications
Have eight years of experience in product compliance testing and certification—hands-on experience on Product Safety, EMI EMC & Environmental standards. • Good Knowledge of various national & International standards. • Experience in dealing with the CE, TEC, BIS, UL, CSA,…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Corporate Affairs, Regulation and Government Relations, External and Internal Communications
With 25 years of senior executive experience in tobacco and getting results in various major markets - from the UK to UAE to Eastern Europe and Russia - Expert can safely say that he has a global perspective on how…
Medical Devices, Business Development, Regulatory Affairs, Project Management
Expert successfully launched over 25 new instrument and disposable medical devices. He developed and managed numerous cross-functional and cross-cultural new product and process teams. He has developed rich experience in team leadership and assembly, grounded in RA/QA fundamentals (RAC Certified).…
Psychopharmacology; Sleep; Depression; Academic Affairs; Compliance; Research
He has been involved in basic and clinical psychopharmacologic research and teaching for more than three decades. He has been funded for his work by federal and state agencies, as well as by industry and foundations. He has more than…
Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…