Asia R. Blackwell
Severn,MD
Summary
Results-driven regulatory affairs leader with over 15 years of progressive experience in healthcare and the U.S. Food and Drug Administration, specializing in CBER policy development and process optimization. Proven ability to direct cross-functional teams, streamline complex regulatory operations, and spearhead enterprise-wide initiatives that enhance communication and consistency. An expert in managing engagement with internal and external partners and strategic planning, poised to drive efficiency and support CBER’s public health mission in a team leadership capacity.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Team Lead (Acting)
Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration
10.2025 - Current
- Provide strategic leadership as Chair of the Letter Template Subcommittee (LTS), directing the modernization and standardization of CBER's official communication templates to align with business objectives and the needs of regulated industry and internal teams.
- Champion process improvement by facilitating CBER Process Implementation and Improvement Team (PIIT) meetings, guiding discussions with RPMs, team leads, and supervisors to identify and resolve critical gaps in regulatory review processes.
- Serve as the Regulatory Correspondence Document Lead (RCDL), managing the full lifecycle of change requests, resolving complex correspondence issues, and serving as the signatory for minor updates to ensure quality and timeliness.
- Authored foundational Division of Regulatory Operations (DROP) Work Instructions for regulatory documents, establishing a clear and efficient process for staff to draft, clear, and approve critical communications.
- Direct change management initiatives by serving as the primary liaison between project teams and the Change Management Team (CMT), developing project plans, and executing communication strategies to ensure smooth adoption of new processes by all affected personnel.
Consumer Safety Officer
Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration
Silver Spring, MD
04.2018 - Current
- Led the CBER Letter Template Subcommittee (LTS), providing strategic oversight to standardize letter templates, which enhanced the clarity, consistency, and regulatory compliance of CBER's communications with external sponsors and applicants.
- Directed the development and implementation of key CBER operational policies and procedures, improving consistency and efficiency across regulatory review and compliance functions.
- Served as CBER’s primary Liaison for Postmarketing Requirements/Commitments (PMR/PMC), reviewing and providing critical feedback on product office letters to ensure completeness and center-wide consistency.
- Managed the final quality control for all CBER Regulatory Job Aids, Templates, and Checklists, ensuring accuracy and compliance before publication to the center-wide SharePoint site.
- Advised senior management on emerging policy issues, providing analysis and proposing strategic program responses to support new agency initiatives and overcome operational barriers.
Health Scientist Administrator
Center for Biologics and Research (CBER), U.S. Food and Drug Administration
Silver Spring, MD
10.2017 - 04.2018
- Served as the Designated Federal Official for the Allergenic Products Advisory Committee (APAC), leading all meeting activities, including agenda development and official adjournment.
- Proactively managed committee membership by coordinating with product offices to fill vacancies, successfully maintaining a vacancy rate of less than 10%.
- Oversaw the preliminary administrative and scientific review of INDs, BLAs, and other health science issues presented to the advisory committee.
Regulatory Health Project Manager
Center for Tobacco Products (CTP), U.S. Food and Drug Administration
Silver Spring, MD
05.2013 - 10.2017
- Managed the scientific and technical review of complex submissions for new tobacco products (PMTA, SE, MRTP), serving as the central liaison between the review team, management, and industry.
- Trained and mentored new Regulatory Health Project Managers on conducting Acceptance and Filing Reviews for the PMTA pathway, improving team competency and review consistency.
- Led the development and vetting of multiple templates for the Premarket Tobacco Application pathway, streamlining the submission and review process.
- Managed contracts funded by the Office of Science (COR II certified) and organized logistics for key engagement programs with industry and scientific partners, including laboratory and manufacturer site tours.
Principal Research Coordination Specialist
Pharmaceutical Product Development (PPD)
Rockville, MD
09.2011 - 05.2013
- Managed the daily operations of a six-member clinical administration team, allocating personnel resources and overseeing project budgets to ensure financial and operational efficiency.
- Provided technical expertise and leadership to the team on reviewing regulatory documents for multiple clinical trials, ensuring compliance with client and federal requirements.
- Developed Standard Operating Procedures (SOPs) and Project Work Instructions (PWIs) to standardize administrative functions and improve project outcomes.
Research Coordination Specialist
Pharmaceutical Product Development (PPD)
Rockville, MD
09.2009 - 09.2011
- Provided technical expertise to the team on reviewing all regulatory documents for multiple clinical trials to ensure compliance with client and federal requirements.
- Prepared, reviewed, and submitted clinical and non-clinical documents to the appropriate regulatory agencies, including the Food and Drug Administration (FDA).
- Managed and tracked all serious adverse events and expedited reports for multiple clinical trials to ensure timely reporting to the appropriate regulatory agencies.
Lead Certified Medical Assistant
Kaiser Permanente
Largo, MD
11.2007 - 09.2009
- Managed the daily workflow of two medical assistants, including delegating tasks, monitoring performance, and providing feedback.
- Trained and mentored new medical assistants on clinical and administrative procedures.
- Served as a point of contact for patient escalations, resolving issues in a timely and professional manner.
Certified Medical Assistant
Kaiser Permanente
Largo, MD
08.2005 - 11.2007
- Provided direct patient care, including taking vital signs, administering medications, and performing phlebotomy.
- Assisted physicians with examinations and procedures.
- Educated patients on their medical conditions and treatment plans.
Education
Masters - Health Services Administration
Strayer University
Washington, DC01-2009
Bachelor of Science - Biology
Morgan State University
Baltimore, MD01-2004
Skills
- Regulatory Leadership: Policy Development, Process Improvement, Change Management, Team Leadership & Mentoring
- Regulatory Expertise: CBER & FDA Regulations, Regulatory Submissions (IND, BLA), Post-Market Compliance (PMR/PMC), Quality Control
- Project Management: Strategic Planning, Cross-functional Team Leadership, Project Lifecycle Management, Contract Management (COR II)
- Communication: Partner & Industry Engagement, Technical Writing, Template Standardization, Public Speaking
Certification
Contracting Officer Representative (COR) Level II | Apr 2017 – Apr 2019
Timeline
Team Lead (Acting)
Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration
10.2025 - Current
Consumer Safety Officer
Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration
04.2018 - Current
Health Scientist Administrator
Center for Biologics and Research (CBER), U.S. Food and Drug Administration
10.2017 - 04.2018
Regulatory Health Project Manager
Center for Tobacco Products (CTP), U.S. Food and Drug Administration
05.2013 - 10.2017
Principal Research Coordination Specialist
Pharmaceutical Product Development (PPD)
09.2011 - 05.2013
Research Coordination Specialist
Pharmaceutical Product Development (PPD)
09.2009 - 09.2011
Lead Certified Medical Assistant
Kaiser Permanente
11.2007 - 09.2009
Certified Medical Assistant
Kaiser Permanente
08.2005 - 11.2007
Bachelor of Science - Biology
Morgan State University
Masters - Health Services Administration
Strayer University