Karen Robertson

Karen Robertson brings over 20 years of regulatory strategy, clinical compliance, and drug development leadership to Attralus. She has earned numerous new molecular entity or supplemental NDA or BLA approvals while maximizing product labeling and fostering successful relationships with global health authorities.

With both large pharma and start-up biotech leadership experience, Karen has deep experience developing and executing strategies for both early and late-stage development and post-approval lifecycle regulatory strategy. She specializes in bringing new therapies and diagnostics to market in unmet need and rare disease areas by establishing efficient paths to approval and positioning programs to be opportunistic with minimal or atypical datasets, such as investigator-initiated study data or real-world evidence.

Prior to coming to Attralus, Karen led a consulting business advising biotech companies on regulatory strategy, regulatory and quality organization development, and product development pathways. Bringing a calm, direct leadership style, Karen enjoys leading teams to assess both risk and opportunity in a development landscape and maximize their interactions with global health authorities in the ever-evolving global regulatory landscape.