Monika is a seasoned executive with nearly two decades of experience in Regulatory Affairs and Technical Operations, with expertise spanning discovery, preclinical, clinical, commercial, and translational research.
At Halloran, she serves as an on-demand executive and interim Head of Regulatory for clients developing biologics and advanced therapies. She collaborates cross-functionally to shape regulatory strategy, advises on pivotal development decisions, and leads key interactions with health authorities. Her leadership includes oversight, authorship, and review of major submissions to the FDA, EMA, and other global agencies.
Previously, Monika led Swietlicka and Associates, where she partnered with early- and late-stage biotech companies to deliver strategic regulatory guidance across the product development lifecycle. She served as a regulatory thought partner for first-in-human programs and late-phase products, helping to drive successful regulatory outcomes and platform positioning. She also supported clients through due diligence processes, licensing evaluations, and regulatory assessments tied to investment and acquisition decisions.
Monika spent seven years as SVP/VP of Regulatory Affairs and Technical Operations at Immusoft, a clinical-stage cell and gene therapy company. There, she spearheaded the regulatory strategy and built the quality infrastructure to support a first-in-human, genetically modified, autologous B-cell product. She also served as a Board Observer, where she contributed regulatory insights to inform executive and investor-level decisions.
Her experience spans a wide range of product modalities, including genetically engineered autologous and allogeneic cell therapies, mRNA and LNP-based platforms, monoclonal antibodies, vaccines, and small molecules. She has supported products addressing rare diseases, infectious diseases, ophthalmic conditions, autoimmune indications, and cancers with high unmet medical need. Monika has also worked on therapeutic delivery systems and combination products requiring novel regulatory strategies.
Throughout her career, Monika has maintained strong relationships with U.S. and European regulators and has played a key role in advancing programs through complex regulatory milestones. She currently serves on the Board of Directors of ORCA (Organization of Regulatory and Clinical Associates), where she contributes to leadership development initiatives for regulatory and clinical professionals in the life sciences. She also supports conference programming, thought leadership, and community education in cell and gene therapy through her role at Halloran, and has maintained a longstanding engagement with the American Society of Gene and Cell Therapy (ASGCT) for over a decade.
Monika holds an MS in Regulatory Science from Johns Hopkins University, an MBA in International Business and a BS in Biochemistry from Seattle Pacific University, and a Certificate in Drug Development from Harvard University.