Regulatory Affairs Specialist II

• Nov 2020 - Present

• Providing regulatory guidance to new product introduction (NPI) teams.• Contributing to cross-functional efforts to develop, review, and approve packaging and labeling materials. Ensuring new products and changes to existing products comply with applicable regulations.• Collaborating with regulatory partners to develop and execute regulatory strategies, including the preparation of FDA submissions.• Providing comprehensive support to regulatory teams, including carrying out competitiveintelligence research, analyzing new and existing FDA guidance, conducting archival regulatory research, preparing regulatory affairs presentations for cross-functional working groups, and performing other regulatory support functions as needed. Show less

Regulatory Affairs Associate - Regulatory Affairs Apprentice Leadership Program

• Jul 2020 - Present

Regulatory Affairs Intern, The International Center for Regulatory Science

• May 2019 - May 2020

Devices • Filed an IDE supplement submission to the FDA for a class I device. • Assisted a client with acquiring a Unique Device Identification for a class II device. • Produced Design Control SOPs: document control, input, output, verification, validation, design transfer, risk, complaint, MDR, and supplier qualification. • Project Lead: Conducted ISO 13485 and CFR 820 gap analyses. Produced an audit checklist compliant to ISO 13485 and CFR 820. Participated in an MDSAP-based audit. Drugs • Produced clinical trial checklists and strategy for a theragnostic molecule and drafted its orphan drug designation request. • Created a pre-IND meeting briefing packet for an orthopedic gene therapy. • Project Lead: Conducted market analyses on pharmaceutical cannabinoid products. Mapped sponsor, molecule, indication, location, and phase-specific advancement in cannabinoid drug development. Supplements • Project Lead: Created a criteria for the FDA approval of petitioned Qualified Health Claims. • Teaching Assistant: regulatory science summer exchange program. Show less

Legal Assistant Intern

• Jun 2014 - Aug 2014

• Translator and interpreter: English and French. • Editing documents and letters. • Documenting and maintaining files and records. • Translator and interpreter: English and French. • Editing documents and letters. • Documenting and maintaining files and records.

Research Intern

• Sep 2012 - May 2014

• Studying the effects of Acetaminophen and Ibuprofen on male reproduction under Dr. G Manku's supervision. • Setting up and conducting experiments: RNA isolation, cDNA synthesis and quantitative real-time PCR. • Studying the effects of Acetaminophen and Ibuprofen on male reproduction under Dr. G Manku's supervision. • Setting up and conducting experiments: RNA isolation, cDNA synthesis and quantitative real-time PCR.