Sandra Vazquez Email & Phone Number

Washington, DC, US

Bethesda

Provide oversight, guidance and expert advice to the VRC Regulatory Science and Strategy Program (RSSP). Provide domestic and global regulatory expertise to nonclinical, clinical, and quality for VRC product portfolio. Ensure dissemination of regulatory intelligence to the Senior Leadership. Collaborate with other teams to establish regulatory pathways..

Bethesda, MD

Regulatory affairs expert responsible for managing an Investigational New Drug (IND) application portfolio of products consisting of vaccines and monoclonal antibodies for compliance with the Food and Drug Administration (FDA) regulations for use in humans. Plan submission strategy, implementation, review processes, and compliance with the FDA, National.

Gaithersburg, Maryland

• Managed regulatory projects from initiation and planning to successful completion and closure: submission and approval of marketing applications in US/EU/ other global regulatory authorities.
• Led cross functional teams in submission and FDA clearance based on foreign data from studies conducted outside of US, not under an IND.
• Represented regulatory functions on product teams and other cross-functional teams for early/mid/late phase infectious diseases drugs/biologics projects, provided regulatory project management for INDs, CTAs and agency.
• Oversaw and developed knowledge sharing forum to facilitate continued learning and expanded skills; fostered collaborations among different functions.
• Planned a parallel scientific advice communications with stakeholders from both EMA and FDA to strengthen and streamline scientific discovery and collaboration for assigned program.

Frederick, MD

Provide advice in medical product development and FDA regulatory process for the United State Army Medical command. Review, editing and coordinating documents to be submitted to the FDA.Attend FDA Meetings and keep track of meeting commitments. Quality review validation reports, IND packages and clinical study reports. Assist in internal and external.

As a Regulatory Specialist at a Clinical Research Organization (CRO) my main responsibility is to serve as liaison between client and the US Food and Drug Administration (FDA) for multiple classes of drugs and devices. Create clinical protocols, regulatory compliance gap analyses, investigator’s brochures, Clinical Report Forms (CFR), Investigational New.

Gaithersburg, MD

Perform stability and lot release immunoassay testing of clinical development samples. Co-lead laboratory compliance of GMP initiatives and organization. Co-lead on technology being transferred to the group. Execute and report test method/ equipment/reagents validation. Participate in the organization of team building activities and community services.

Frederick, MD

Perform in-process and stability samples immunoassay testing for market products following GMP initiatives and CMC specifications. Conduct OOS and deviation investigation. Maintain Standard Operating Procedures (SOP) up to date. Maintain laboratory equipment including validation execution. Conduct Corrective Action/Preventive Action (CAPA) investigations..

Carmel, NY

Create Raw Material, Finished Product, and Microbial Test Methods procedure documents based on Analytical R&D Validation Reports and US Pharmacopeia regulations. Assisted in the preparation, coordination, attendance and participation in document Change Control Request Meetings for implementation into Test Methods.

New York, NY

Coordinated production and organization of R&D related Test Methods and Work Instructions SOP's. Participated in analytical method development, testing, qualification and validation. Participated in nonconformance investigation related to product performance. Supported internal audits. Performed QC release testing, raw material inspection and Batch record.

Barceloneta, PR

Coordinated and investigated external level II and level III customer complaints. Provided information and analysis summarizing results of complex data to be presented to Management. Performed Trending and Tracking of performance metrics and product complaints to identify problems and/or potential issues and to assure that appropriate Corrective and/or.

Master Of Science - Ms, Regulatory Science

Ms, Molecular Biology

Ms, Bioscience Regulatory Affairs

Bs, Biology