Senior Level Regulatory Manager with boundless passion for advancing medical discoveries looking for better advancement opportunities - Regulatory Affairs. Dynamic career reflecting award winning performance, proven drug development and medical education experience. Has expert knowledge of preclinical and clinical R&D and the overall drug development process. Primary responsibilities involved developing global CMC/Clinical regulatory strategies and content plans to support pre-approval and post-approved products. Ensured the development strategy meets global regulatory requirements over the lifecycle of the product and ensured CMC/Clinical regulatory strategy is in alignment with Clinical Development Plan (CDP) and global regulatory strategy (GRASP), therapeutic area portfolio, and the Target Product Profile (TPP). This works centers on research and analysis of proprietary (pre) clinical data and provided regulatory expertise for investigational and post-approval products. Highly skilled at creating, planning and implementing goals, objectives and practices for cost effective time management. Highly skilled in scientific writing and editing and gifted in communicating complex technical information at an appropriate level to a wide variety of audiences. Have great passion for working collaboratively & truly enjoys mastering new concepts. Medicinal Chemistry, Pharmacology, Product Development, Biostatistics and Management * Therapeutic Areas: Oncology, Neuroscience, CVD, Inflammation, Infectious and Lung Diseases, Tissue Repair, CNS, Rare Diseases, and Immuno-Oncology * Expert on Drug Development process * Knowledge of clinical trial regulations

Highlights:

• Chemistry
• Filing
• Oncology
• Regulatory Affairs
• Due Diligence
• Management
• Therapy
• Planning
• Medical
• Medical Affairs