Jana Highsmith
Consumer Safety Officer - Regulatory Project Manager
- Role
- Regulatory Project Manager at FDA
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
About Jana Highsmith
Administrative/coordinating member of a multi-disciplinary team that reviews, evaluates, and implements administrative and regulatory action in relation to scientific submissions and applications for new oncology drug products.
Experience
Regulatory Project Manager
Mar 2022 — Present
Regulatory coordinating member of the Application Review Branch located within the Office of Compliance and Biologics Quality (OCBQ), Division of Manufacturing and Product Quality (DMPQ), which ensures the quality of products regulated by CBER over their entire lifecycle through pre-market review and inspection, and post-market review, surveillance, inspection, outreach, and compliance-Provide expertise in the area of biological drug and/or device manufacturing and procedures-Review and evaluate plans developed by various components to establish a uniform plan for the division-Provide oversight of regulatory responsibilities and operational functions-Provide information to offices assigned to handle regulatory actions-Review annual reports submitted in accordance with 21 CFR 601.12(d) by Sponsors to the FDA-Manage presubmission and facility meeting requests submitted by Sponsors/Applicants-Manage the DMPQ review team for original Biologics License Applications; setting up monthly meetings, sending requests for additional information to Applicant, circulating OCBQ/SBRA, and ensuring compliance checks are done-Manage Biologics License Supplements (Changes Being Effected (CBE), CBE-30, and Prior Approval Supplements related to CMC Facilities Changes)
Education
American Public University
Master's , Public Health
Bowie State University
Biology, General
The George Washington University
Master’s Certificate, Project Management
2017 — 2018
American Public University
Bachelor of Business Administration - BBA, Marketing
Skills
- Public Speaking
- Business Analysis
- Budgets
- Community Outreach
- Process Improvement
- Non-Profits
- Ap Style
- Html
- Management
- Outlook
- Federal Government
- Microsoft Office
- Sales
- Research
- Newspaper
- Social Media
- Event Planning
- Social Media Marketing
- Microsoft Excel
- Powerpoint
- Recruiting
- Online Advertising
- Coaching
- Sap Bw
- Public Relations
- Troubleshooting
- Peoplesoft
- Sap
- Account Management
- Employee Benefits
- Marketing Communications
- Social Networking
- Internal Audit
- Policy
- Database Administration
- Training
- Editing
- Microsoft Word
- Strategic Planning
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