Leadership
Jessica Kokosinski
Jessica founded Auctoria Regulatory to bring seasoned CMC regulatory judgment to companies at every stage, from first-in-human through approval and beyond. She draws on more than 25 years in the pharmaceutical industry, more than 15 of them in CMC regulatory affairs, and works as an extension of her clients’ teams rather than an outside voice. Clients rely on her to translate complex chemistry, manufacturing, and controls requirements into defensible regulatory strategy, anticipate Health Authority expectations before they become obstacles, and keep programs moving without compromising rigor.
Most recently, Jessica held a vice-president-level role at a global regulatory consultancy, where she built and scaled an international regulatory team and grew client relationships ranging from emerging biotechs to top-20 pharmaceutical companies. Her regulatory career began in plasma protein therapeutics. She has since led CMC strategy and submissions across monoclonal and bispecific antibodies, antibody-drug conjugates, vaccines, peptides, and cell-based therapies, for both blockbuster products and rare disease programs.
Before regulatory affairs, Jessica conducted academic research at the Johns Hopkins University School of Medicine, worked as a QA auditor, and managed cross-functional projects. That foundation is why she reads a submission the way reviewers and inspectors do.
Founder & PrincipalOur Model
Every Auctoria Regulatory engagement is led personally by Jessica. When a program calls for additional depth or capacity, she draws on a trusted network of senior regulatory professionals, each matched to the work rather than assigned from a bench.
Client Perspectives
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"Brought on with limited hours, they hit the ground running from day one. The kind of support any client would be lucky to have."
Leading Global Biopharmaceutical Company
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"They joined mid-project to cover a critical NDA gap and quickly earned a bigger role, taking on additional sections as the work demanded. They made the effort to meet our subject matter experts in person and understood our processes faster than we expected. Now they're the one we trust to represent our CMC function in cross-team meetings — organized, responsive, and genuinely a pleasure to collaborate with."
Oligonucleotide Biopharmaceutical Client
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"What stood out was how quickly they got up to speed — grasping our team dynamics, spotting gaps, and understanding the 'why' behind them almost immediately. They came to every meeting prepared, with clear objectives and materials ready in advance. Easy to work with, and always kept our project managers in the loop."
Biopharmaceutical Company focused on Rare Diseases