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. Bring innovative, evidence based, regulatory approaches, to leadership to find the best early regulatory development strategies for novel products. Integrate multiple inputs from teams, to create and execute a regulatory strategy, and, refine as new data becomes available. Represent regulatory on the multi-functional teams, provide risk/benefit evaluations associated with regulatory strategies. Accountable for regulatory advice to VRC senior leadership. Provide input on design, strategic decisions, conduct of clinical studies, monitoring and identify risks, and the need of additional information to ensure regulatory compliance. Communicate and collaborate with other regulatory experts within NIH to leverage institutional knowledge. Evaluate emerging regulations and changing regulatory landscape for impact and provide strategic advice for the VRC's portfolio. Lead procedures for working with Regulatory Authorities (RAs/HAs). Accountable for the preparation and eCTD submission of regulatory docs for US and other RAs. Coordinate with nonclinical, clinical, and manufacturing teams to develop regulatory submission plan. Establish Rapid Response Team, to develop/coordinate responses to RAs’ inquiries. Strategize RAs interactions in collaboration with relevant VRC experts. Prepare and assist VRC experts during external RA interactions. To enable FIH studies, assist in the development of GLP pre-clinical/ nonclinical safety testing plans, review data from nonclinical, tox studies, nonclinical safety testing protocols and reports. Contribute to the development of Good Practices: GDP,GCP,GMP, GCLP, GLP processes and guidance.

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 Institutes of Health (NIH) and international regulatory authority regulations.Assist in clinical protocol review, management of regulatory affairs, and quality assurance support for product development efforts involving Phase I and II human trials conducted according to Good Clinical Practices. Write and review documentation for compliance with FDA Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and/or current Good Manufacturing Practice (cGMP). Responsible for the management and quality of the Investigational New Drug (IND) application and amendments throughout its lifecycle which includes writing, reviewing and/or editing the initial IND eCTD submission, IND amendments, Investigator Brochures and FDA annual reports. Interact with FDA project managers routinely, and be responsible for pre-consultation and pre-IND meetings and meeting packages, and responses to FDA queries. Report to the Director of the RSSP to ensure Sponsor responsibilities are met. Support the RSSP by developing standard operating procedures (SOPs), evaluating emerging regulations and changing regulatory landscape for impact and provides strategic advice for the VRC’s portfolio, and communicating with VRC stakeholders which may include recommending applicable education and training to VRC personnel for assurance of regulatory compliance Serve as liaison between the Office of Regulatory Science at the VRC and other components of the VRC involved in product development and serve on product development teams as the regulatory expert.

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 interactions.• 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 compliance audits. Follow up department of defense acquisition milestones. Follow up on departments of defense internal policies.

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 Drug (IND) Annual Reports, IND submissions, FDA meeting briefing packages and FDA response letters. Attend FDA Meetings and keep track of meeting commitments. Quality review validation reports, IND packages and clinical study reports. Assist in internal and external compliance audits. Perform literature research, data mining of pre-clinical human exposure to contribute to client’s clinical development plan analyses. Monitor safety of clinical trials. Serve as primary point of contact and represents team activities. Manage the activities of the review team. Monitors and reports status of all activities within the assigned projects. Assure the timely completion of project activities and attainment of project objectives. Identify project activities or situations that may adversely impact project plans. Advise supervisors, team members, and management of potential impact of problems and other technical information. Review a variety of drug submissions for Chemistry, Manufacturing Controls (CMC), pharmaceutical, administrative and legal compliance prior to the final submission to FDA. Monitor drug submissions from initial receipt to completion for one or more classes of drugs to ensure regulatory compliance. Serve as point of contact between FDA and Sponsor concerning the application submission process. Communicate with staff members and senior management to exchange information regarding assignments.

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. Support internal and external audits.

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 review.

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 Preventive actions (CAPA) are initiated. Supported Division, Corporate and ISO audits. Verified the effectiveness of Corrective and/or Preventive Actions implemented.

Master Of Science - Ms, Regulatory Science

Ms, Molecular Biology

Ms, Bioscience Regulatory Affairs

Bs, Biology