Synthia Larson

Director, Regulatory Affairs and Project Management @ Clene Nanomedicine, Inc.

About

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.

Country

United States

City

Salt Lake City

Industry

Pharmaceuticals

Skill

Electronic Document Management System (EDMS), Organization Skills, Marketing Authorisation Application (MAA), Oral Communication, Timelines, Supplier Evaluation, Data Integrity, Skill Development, Product Quality, ICH, Regulatory Agencies, Drug Development, Regulatory Filings, Regulatory Requirements, Life-cycle Management, Pre-clinical Studies, CMC development, Strategic Thinking, New Drug Application (NDA), Electronic Common Technical Document (eCTD)

Experience

Director, Regulatory Affairs and Project Management

Clene Nanomedicine, Inc.

2023-10 - Present · 3 yrs

Salt Lake City Metropolitan Area

Director, CMC R&D Technical Services

Teva Pharmaceuticals

2021-10 - 2023-10 · 2 yrs 1 mo

Salt Lake County, Utah, United States

Manage direct reports and lead site R&D in regulatory submissions. Oversaw the execution of CMC-related development and manufacturing activities between R&D and commercial facilities, including product launches and CBE/PAS with health authority approvals to sustain commercial product lines.

Associate Director, Analytical R&D

Actavis plc (now Allergan)

2014-6 - 2021-9 · 7 yrs 4 mos

Salt Lake County, Utah, United States

Manage direct reports and lead R&D analytical teams, specification setting, change control, and documentation. Authored and reviewed regulatory product applications (ANDA, ANDS, and NDA) with product approvals. Technical CMC lead on submissions and responses to regulatory agencies.

Sr. Manager, Technical Services

WATSON PHARMACEUTICALS (NEW JERSEY) INC

2004-6 - 2014-6 · 10 yrs 1 mo

Salt Lake County, Utah, United States

Manage direct reports in support of Analytical documentation and change controls. Achieved cross-function team alignment in department creation and use of electronic templates in support of eCTD filing requirements resulting in ANDA acceptance for technical review.

Quality Assurance Consultant

Pharmaceutical Systems, Inc.

2002-11 - 2004-2 · 1 yr 4 mos

Audited manufacturing processes of various drug formulations for cGMP compliance. Implemented new Master Production & Control Records (MPCR) and site SOPs to address non-compliance issues and corrective actions under client's CAPA.

Reseach Associate

Myriad Genetics

1998-1 - 2002-8 · 4 yrs 8 mos

Created computational tools for multiple collaborations focused on genome and proteome data. Modified relational databases for information display according to data types and end user needs.