Meredith Brown-Tuttle
Executive Director, Regulatory Affairs @Crinetics Pharmaceuticals
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WORK HISTORY
Executive Director, Regulatory Affairs @Crinetics Pharmaceuticals
San Diego, CA, US
EDUCATION
San José State University
BA, Neuroscience
University of California, Santa Cruz
Clinical Trials Design and Management
SKILLS
ABOUT MEREDITH BROWN-TUTTLE
Global Regulatory Affairs experience in 42+ countries including:Strategy and Intelligence: Created and managed global Regulatory Strategy for drugs, devices and combination productsConducted Regulatory Research and Intelligence on a global scale for various therapeutic indicationsPerformed strategic gap analyses to identify potential issues to successful IND, NDA, MAA and BLA filingsSubmissions:INDs, CTAs, IMPDs, NDA, MAA, Orphan Drug Designations (EU & US), PIP, PSP, Fast Track Designation requests, QIDP, trade name requests, DSUR, 510(k), PMA, PSUR,+ amendmentsAgency Interactions:US, Canada, EU, India, Australia, Africa and Eastern EuropeMarketing Applications Written/Planned/Submitted: 505(b)(1), 505(b)(2) and hybrid: New Drug Application (NDA) and Marketing Authorization Application (MAA) Meetings:Wrote and compiled associated packages for both FDA, Health Canada, EMA and EU agency meetingsConducted in-person or teleconferences with the FDA and EMA Countries:Wrote and coordinated regulatory submissions for: United States, Australia, Canada, Eastern Europe, Europe, Israel, India, Latin America, Middle East, Singapore, South Africa and South America.Commercial Product Experience:•Wrote, reviewed and approved labeling (package inserts, carton, vials) for US and EU drug and device products•Reviewed promotional materials (press releases, web sites, advertising/marketing materials, call center scripts)•Reviewed State regulatory requirements for commercial product distribution and licensing•Assisted with Establishment & Drug Listing and NDC number registrationPublished \"IND Submissions: A Primer,\" Regulatory Intelligence, regulatory strategy, regulatory research,global regulatory submissions, writing and compiling submissions, protocols and investigator\'s brochures
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