From molecule inception and onwards, Dr. Julie Rosenberg has years of deep drug development experience, allowing her to bridge scientific knowledge and practical execution. She’s led cross-functional teams and initiatives at Pfizer, Bayer Healthcare, Bristol-Myers Squibb, Boehringer Ingelheim, and countless small- and medium-sized biotech companies.
Her sophisticated understanding of cross-border collaboration ensures team alignment across regions and regulatory environments. Dr. Rosenberg’s ability to adapt to diverse cultural and professional landscapes makes her an invaluable asset to any global drug development team.
Proven Track Record
Knowledge of Multiple Regulatory Authorities
Dr. Rosenberg has cultivated deep expertise in engaging with global regulatory authorities, including the FDA, EMA, and PMDA.
Her proven track record includes supporting successful regulatory submissions, navigating resubmissions, and helping to ensure compliance with evolving international standards. She is able to support organizations in achieving their goals from the inception of the molecule onwards by optimizing trial designs, delivering comprehensive drug development strategies, and securing regulatory approvals that pave the way for market success.
Fractional Leadership
Comprehensive Oversight & Tactical Execution
Dr. Rosenberg excels in both strategic and day-to-day roles. This includes overseeing a complex drug development program to assisting a team with unmet day to day clinical needs. Her on-the-ground skill set spans regulatory submissions, medical monitoring, data review, single-case and aggregate safety review and the creation of clinical study protocols and reports.
This balance of high-level vision and hands-on expertise enables her to identify and resolve challenges efficiently, ensuring streamlined progress through every stage of drug development.
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Julie Rosenberg, MD is a senior life sciences consultant with a proven track record of success in leading global drug development and pharmacovigilance programs.
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