Amanda Le Email and Phone Number

As a seasoned professional with over a decade in business development cum regulatory affairs and four years in quality assurance within the global pharmaceutical sector, I have cultivated a deep understanding of the complexities inherent in strategic business development initiatives, market analysis, and drug registration processes. One of my key strengths lies in collaborating with multi-stakeholders, where I bring together business, regulatory acumen and interpersonal skills to achieve common goals. I thrive in analyzing complex queries from various health authorities in diverse Asian countries, Canada and manufacturers, assessing their impacts, and solving problems in varied and challenging situations.Professional Strengths:• Market Research and Analysis: conducted comprehensive market research to identify potential trading opportunities, market trends, competitor activities. Analyzed market data to develop strategic business plan and identify new avenues for growth in pharmaceutical trading operations.In-Depth Knowledge of Local and International Regulations: Canada, FDA, Asian countries, EMA.• Proficiency in translating intricate regulatory requirements into practical and feasible strategies.• Effective Organizational and Project Management Abilities.• Adept at fostering effective communication and collaboration across diverse stakeholders for successful business and regulatory outcomes.• Demonstrated strategic thinking and problem-solving skills, manage and prioritize multiple projects to overcome regulatory challenges and drive success.• Expertise in Regulatory Compliance, Pharmacovigilance, and Quality Assurance Systems.• Proficient in ICH guidelines, GCP guidelines and well-versed in the intricacies of clinical trial processes.• Familiarity with Drug registration and expertise in submission preparation and Review.Academically, I hold a Diploma in Professional Regulatory Affairs from the esteemed Academy of Applied Pharmaceutical Science in Ontario, Canada. My foundational knowledge comes from a B.Sc. degree in Pharmaceutical Sciences earned at Hanoi University of Pharmacy, Vietnam.Let's connect! I am eager to explore new opportunities for collaboration, share insights, and contribute to the ever-evolving landscape of international pharmaceutical business development and regulatory affairs.Contact information: amanda.levu@gmail.com