With over two decades of experience in the pharmaceutical industry, I have demonstrated expertise in ensuring regulatory compliance with agencies such as USFDA, TGA, WHO, MHRA, KFDA, and Mexican Regulatory Agency. My proficiency in ISO GMP standards has been instrumental in maintaining impeccable quality and safety in pharmaceutical manufacturing. I specialize in API manufacturing, with a particular focus on oncology drugs, and have contributed significantly to their development. Throughout my career, I've held key roles in pharmaceutical companies, managing regulatory affairs, quality control, and manufacturing operations. My leadership and teamwork skills have enabled me to successfully lead complex projects and cross-functional teams.
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