Sofia Thomas Email & Phone Number

I am deeply passionate about drug research and regulatory science, with a strong background in the intricacies of drug development and compliance within the global regulatory framework. Currently, I am pursuing a Master’s in Regulatory Affairs for Drugs, Biologics, and Medical Devices at Northeastern University, where I focus on critical areas such as FDA regulations, ICH guidelines, and clinical trial oversight.With hands-on experience in GCP/GVP quality assurance at Alnylam Pharmaceuticals and as a clinical pharmacist intern in hospital settings, I have developed a keen understanding of regulatory submissions (NDA, BLA, 510(k)), pharmacovigilance, and clinical trial management. I have actively contributed to risk assessments, vendor qualifications, and optimizing standard operating procedures (SOPs) to enhance compliance with regulatory standards.In addition to my clinical expertise, I am skilled in document control, CMC, IND submissions, and regulatory strategy development, ensuring the safe and effective commercialization of therapies. I am particularly driven by improving patient safety and regulatory compliance through meticulous monitoring of adverse drug reactions and optimizing clinical protocol adherence. My scientific acumen, combined with a strategic understanding of regulatory pathways, allows me to contribute meaningfully to the development and approval of innovative therapies.I thrive in collaborative environments and am committed to advancing regulatory standards in the biotech and pharmaceutical industries.

Listed skills include Tax, International Tax, Income Tax, Tax Advisory, and 3 others.