Theresa Sofka

Background

About Theresa Sofka

Dedicated and seasoned Regulatory Affairs Labeling Specialist with over 17 years of experience in the pharmaceutical industry. Throughout my career, I've held key roles such as Labeling Associate, US Labeling Specialist, and Regulatory Affairs Consultant, honing expertise in crafting, reviewing, and supervising regulatory documentation for FDA submissions. At Parexel, I provided specialized consulting services, ensuring compliance with regulatory changes in labeling content while collaborating with cross-functional teams to validate alignment between labeling content and marketing claims. My tenure at Bristol Myers Squibb involved directing the creation and publishing of US labeling submission materials, mitigating risks, and providing expert counsel on FDA labeling requirements. Previously, at Sandoz, Teva, and URL Pharma, I played pivotal roles in developing, analyzing, and supervising regulatory documentation for pharmaceutical products, ensuring strict adherence to FDA regulations and addressing deficiency letters promptly. My experience extends to overseeing labeling files, collaborating with change control systems, and managing adverse events and product complaints. I am currently pursuing certifications in Biomedical Science, Bioengineering, and Biotechnology through Alison Online, enhancing my knowledge base to stay abreast of industry advancements. My skill set includes proficiency in Change Control Management, Document Control, FDA Regulations, Product Lifecycle Management, and Regulatory Agency Submission Applications. I am adept at using various software platforms including Microsoft Office, eCTD, i4i SPL Systems, CCDS, Trackwise Databases, and Veeva Vault. Known for my attention to detail, adaptability, and strong interpersonal skills, I excel in problem-solving and effective communication, facilitating seamless collaboration across diverse teams. I am actively seeking opportunities as a Regulatory Labeling Associate where I can leverage my extensive experience and contribute to regulatory compliance and labeling excellence in a dynamic environment. Let's connect and explore how we can drive regulatory success together.