Synthia Larson
Director, Regulatory Affairs and Project Management @Clene Nanomedicine, Inc
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WORK HISTORY
Director, Regulatory Affairs and Project Management @Clene Nanomedicine, Inc
Salt Lake City, UT, US
EDUCATION
Univ. Wisconsin-Madison
Bachelor of Science (BS), Biochemistry
SKILLS
ABOUT SYNTHIA LARSON
Results oriented professional with 20+ years of pharmaceutical industry experience encompassing regulatory risk mitigation and product life cycle management with R&D and commercial teams. Expertise spans RA-CMC strategic alliance on regulatory submissions for new drug/complex dosage forms/ANDAs, global quality standards including ICH, FDA and EMA, and progressive knowledge in drug/device combination products as it relates to regulatory environment. Additional strengths include:• Well versed in CFRs, cGMP/cGLP, and change management including technical writing expertise in SOPs, investigative summaries, and regulatory submissions.• Advanced principles and practices in Program Development with emphasis on product life cycle management, Project Management (PM) administration, Quality Management Systems (QMS) including procurement and contract services with CMO/CROs.• Strong communication skills, verbal and written, while working cooperatively with other departments and key stakeholders.
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