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Shani Smith Email & Phone Number

Results driven leader with 20 years of FDA experience which includes drug master files, dietary supplements, medical devices, and GLP. at FDA

Location: Glen Burnie, Maryland, United States 4 work roles 3 schools

1 work email found @fda.gov LinkedIn matched

✓ Verified July 2026 4 data sources Profile completeness 100%

Current company

FDA

Role

Results driven leader with 20 years of FDA experience which includes drug master files, dietary supplements, medical devices, and GLP.

Location

Glen Burnie, Maryland, United States

Company size

14770 employees

Who is Shani Smith? Overview

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Quick answer

Shani Smith is listed as Results driven leader with 20 years of FDA experience which includes drug master files, dietary supplements, medical devices, and GLP. at FDA, a with 14770 employees, based in Glen Burnie, Maryland, United States. AeroLeads shows a work email signal at fda.gov and a matched LinkedIn profile for Shani Smith.

Shani Smith previously worked as Senior Regulatory Program Manager at Fda and Research Officer at Fda. Shani Smith holds Master'S Degree, Cybersecurity Policy And Management from University Of Maryland University College.

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Email format at FDA

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{first}.{last}@fda.gov

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AeroLeads found 1 current-domain work email signal for Shani Smith. Compare company email patterns before reaching out.

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Profile bio

About Shani Smith

Results driven leader with 18 years of regulatory experience which includes evaluating analytical and manufacturing data of dietary supplements to ensure quality and safety, accessing biocompatibility and sterilization procedures of medical devices, communicating with international standards organization regarding FDA policy on medical devices, and adhering to quality in regulatory science by following good laboratory practice (GLP). Acquired cybersecurity policy experience to implement risk management strategies to protect critical infrastructure sectors such as healthcare, financial, and critical manufacturing.My research and expertise have allowed the Office of Compliance and Office of the Chief Counsel to enforce regulatory actions per FDA statutes.

Listed skills include Chemistry, Laboratory, Leadership, Management, and 15 others.

Current workplace

Shani Smith's current company

Company context helps verify the profile and gives searchers a useful next step.

Fda

Results driven leader with 20 years of FDA experience which includes drug master files, dietary supplements, medical devices, and GLP.

silver spring, maryland, united states

Website

fda.gov

Employees

14770

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Company profile

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4 roles

Shani Smith work experience

A career timeline built from the work history available for this profile.

Senior Regulatory Program Manager

Current

Fda

Feb 2022 - Present

Research Officer

Fda

Washington D.C. Metro Area

In this position I am responsible for evaluating the chemistry sections of New Dietary Ingredient Notifications submitted to the FDA. Additionally, I evaluate evidence submitted by the FDA Office of Compliance to determine whether or not dietary supplements on the market are adulterated.

Jan 2016 - Feb 2022

Senior Regulatory Reviewer

Fda

Silver Spring Md

As a Senior Regulatory Reviewer, I had the following responsibilities: • Performed comprehensive, scientifically-based pre-market application reviews and evaluations of infection control devices. • Provided sterilization and biocompatibility consults for 510(k) submissions • Provided sterilization consults for CDRH Office of Compliance inquiries. • Evaluated bench and animal testing submitted by industry in the pre-market application. • Prepared… Show more As a Senior Regulatory Reviewer, I had the following responsibilities: • Performed comprehensive, scientifically-based pre-market application reviews and evaluations of infection control devices. • Provided sterilization and biocompatibility consults for 510(k) submissions • Provided sterilization consults for CDRH Office of Compliance inquiries. • Evaluated bench and animal testing submitted by industry in the pre-market application. • Prepared correspondence to industry recommending clearance of infection control devices based upon data submitted by industry. • Served as an FDA sterilization product liaison to a global medical device standard body (AAMI/ISO). Show less

Jun 2011 - Jan 2016

Chemist

Fda

Laurel, Md

Performed analytical chemistry methods such as LC-MS/MS to detect drug residues in food producing animals. Became first author of article “Simultaneous screening and confirmation of multiple classes of drug residues in fish by liquid chromatography-ion trap mass spectrometry” accepted for publication in Journal of Chromatography A.

Mar 2004 - Jun 2011

Team & coworkers

Colleagues at FDA

Other employees you can reach at fda.gov. View company contacts for 14770 employees →

NK

Nicole Kornspan Colleague at FdaRockville, Maryland, United States View → JP

Johnny Pham Colleague at FdaSilver Spring, Maryland, United States View → NE

Nora Etz Colleague at FdaGermantown, Maryland, United States View → PK

Prabha Kc, Ph.D. Colleague at FdaWashington Dc-Baltimore Area, United States View → CB

Courtney B. Colleague at FdaWashington, District Of Columbia, United States View → EW

Edward Webman Colleague at FdaRockville, Maryland, United States View → CT

Christina Thompson Colleague at FdaWashington Dc-Baltimore Area, United States View → SP

Svetlana Petrovskaya Colleague at FdaRockville, Maryland, United States View → KH

Karla Hanes Colleague at FdaWashington Dc-Baltimore Area, United States View → RC

Ricardo Cotte-Emmanuelli Colleague at FdaSan Juan, Puerto Rico View →

3 education records

Shani Smith education

Master'S Degree, Cybersecurity Policy And Management

University Of Maryland University College

Master Of Science (M.S.), Chemistry

North Carolina State University

Bachelor'S Degree, Chemistry

Tennessee State University

FAQ

Frequently asked questions about Shani Smith

Quick answers generated from the profile data available on this page.

What company does Shani Smith work for?

Shani Smith works for FDA.

What is Shani Smith's role at FDA?

Shani Smith is listed as Results driven leader with 20 years of FDA experience which includes drug master files, dietary supplements, medical devices, and GLP. at FDA.

What is Shani Smith's email address?

AeroLeads has found 1 work email signal at @fda.gov for Shani Smith at FDA.

Where is Shani Smith based?

Shani Smith is based in Glen Burnie, Maryland, United States while working with FDA.

What companies has Shani Smith worked for?

Shani Smith has worked for Fda.

Who are Shani Smith's colleagues at FDA?

Shani Smith's colleagues at FDA include Nicole Kornspan, Johnny Pham, Nora Etz, Prabha Kc, Ph.D., and Courtney B..

How can I contact Shani Smith?

You can use AeroLeads to view verified contact signals for Shani Smith at FDA, including work email, phone, and LinkedIn data when available.

What schools did Shani Smith attend?

Shani Smith holds Master'S Degree, Cybersecurity Policy And Management from University Of Maryland University College.

What skills is Shani Smith known for?

Shani Smith is listed with skills including Chemistry, Laboratory, Leadership, Management, Problem Solving, Statistics, Strategic Planning, and Teaching.

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