Jessica Gillum
MD
Summary
Biologics Senior Regulatory Policy Analyst with 17 years of expertise in regulatory compliance and affairs. Focused on drug, biologic, and medical device policy, with a strong command of FDA and CMS regulations. Proven ability to lead cross-functional teams in developing regulatory strategies and ensuring adherence to federal, state, and international standards. Skilled in analytical, statistical, and problem-solving techniques within the biopharmaceutical sector.
Overview
10
10
years of professional experience
Work History
Senior Regulatory Policy Analyst (Biologics)
Food & Drug Administraion
Silver Spring, MD
09.2023 - Current
- Spearheaded regulatory policy analysis for biologics and drug products, ensuring adherence to FDA, and other pertinent global regulatory bodies.
- Draft and submit regulatory filings, including INDs (Investigational New Drugs), BLAs (Biologics License Applications), and other regulatory documents.
- Led analysis and interpretation of the Paperwork Reduction Act (PRA) to ensure compliance with federal mandates on information collection, reporting, and recordkeeping.
- Conducted cost benefit analysis and regulatory impact assessments to evaluate the economic and administrative impact of new policies related to information collection.
- Provided consulting expertise to IT development teams on FDA regulatory processes for data collection optimization required by congressional mandates.
Policy Analyst (Biologics)
Food & Drug Administration
Silver Spring, MD
03.2022 - 09.2023
- Assisted with the development of long-term strategic plans to support policy objectives.
- Collaborated with quality assurance, clinical, and legal teams to resolve regulatory issues.
- Facilitated communication between internal departments regarding any changes made by policymakers.
Policy Analysts (Office of Commissioner)
Food & Drug Administration
Silver Spring, MD
02.2015 - 05.2022
- Formulated strategies to tackle public policy challenges facing FDA Commissioner.
- Conducted research on pertinent topics to enhance decision-making processes of FDA Commissioner.
- Served as a liaison between the FDA Commissioner and external stakeholders, businesses, non-profits.
Education
Bachelor of Science -
Bowie State University
Bowie, MD06-2009
Skills
- Drug and biotechnology policy analysis
- Regulatory compliance and reporting
- Project management and leadership
- Legal and impact analysis
- Cost-benefit evaluation
- Problem resolution strategies
- IT tool development
- Data collection optimization
Timeline
Senior Regulatory Policy Analyst (Biologics)
Food & Drug Administraion
09.2023 - Current
Policy Analyst (Biologics)
Food & Drug Administration
03.2022 - 09.2023
Policy Analysts (Office of Commissioner)
Food & Drug Administration
02.2015 - 05.2022
Bachelor of Science -
Bowie State University
Similar Profiles
Jose Juan GalvezJose Juan Galvez
Deputy Director at Office of Strategic Programs (OSP) / Center for Drug Evaluation and Research (CDER) / Food and Drug Administration (FDA)Deputy Director at Office of Strategic Programs (OSP) / Center for Drug Evaluation and Research (CDER) / Food and Drug Administration (FDA)
Melinda FinleyMelinda Finley
Department Manager at Smiths Food And DrugDepartment Manager at Smiths Food And Drug
Carsyn RossCarsyn Ross
Customer Service Representative at Smiths Food And DrugCustomer Service Representative at Smiths Food And Drug
Seth MillmanSeth Millman
Teacher | ELA, Journalism, AVID | Literacy at Theodore G. Davis Middle SchoolTeacher | ELA, Journalism, AVID | Literacy at Theodore G. Davis Middle School
Lilia HinojosaLilia Hinojosa
Server at Restaurant IndustryServer at Restaurant Industry