Leadership in Regulatory Strategy:*Spearhead regulatory strategy initiatives, including preparation and submission of FDA EOP2 meeting materials, resulting in a successful transition to Phase 3 clinical research.*Leverage Breakthrough Therapy Status and FDA Type D meetings, expediting critical Agency communications and agreements.Regulatory Submissions:*Lead the preparation, review, and submission of cross-functional regulatory filings, including Clinical Study Reports (CSRs), Pediatric Study Plans (iPSPs), Waiver Requests, and IND amendments.*Contributing author and reviewer to eCTD Modules 1-5 documents, with particular expertise in Module 3 (Quality/CMC)Global Regulatory Contributions:*Manage the submission of international DMFs, ASMFs, and IMPD-Qs, ensuring compliance with global regulatory requirements and expanding research reach to multiple countries.*Support DEA licensing and import processes for controlled substances, enabling timely initiation of clinical trials.

*Responsible for the coordination and completion of site start-up activities for clinical trials including regulatory documentation, contract and budget negotiation, and compliance with GCP standards*Primary contact for 25+ clinical research sites, provided clear communication via telephone and email with principal investigators and research staff; exercised skills in influencing without direct authority

*Responsible for the manufacture and quality testing of FDA-regulated products according to current Good Manufacturing Practices (cGMP); initiated internal process improvements to mitigate risks and streamline work flows*Collaborated on new product launches with R&D, Quality Assurance; developed protocols, integrated product into database systems; supported validation engineering projects for FDA-regulated products

*Identified productivity and efficiency issues, developed process improvements for product areas