Alonso Guzman Email & Phone Number

As a Regulatory Operations and Regulatory Affairs professional with extensive experience in the pharmaceutical industry, I have helped clients worldwide gain timely and cost-effective approval for their medicines. My solid understanding of the drug development process and international regulatory submission requirements has earned high marks from our current clients for our reliability, flexibility, fast response, and turnaround submissions regardless of complexity. We provide a range of services, including US Agent services, regulatory operations strategy services, project management, submission document preparation, and global publishing. With vast experience in all types of global regulatory submissions, we are committed to helping our clients succeed.Alonso GuzmánPresident and CEOConsultant Cambridge RegulatoryCambridge, MA+1 617 669 3566 cellaguzman@consultantcr.comwww.consultantcr.com

Boston, Ma, Us

Regulatory Operations Lead, supervising submission and publishing management activities. Responsible for managing the publishing and archiving functions, the dossier management functions, and lifecycle submission—primary system administrator for the day-to-day administration of Veeva RIM Vault.

Boston, Ma, Us

Regulatory Operations Lead Consultant, supervising all submission and publishing management activities. Responsible for managing both the publishing and archiving functions and the dossier management functions and lifecycle submission. Primary system administrator for the day-to-day administration of Veeva RIM Vault.

Cambridge, Massachusetts, Us

Responsible for managing regulatory activities supporting Anokion US subsidiary's projects and programs.

San Diego, Ca, Us

Responsible for daily operations activities preparing all US regulatory submissions, and collaborating with the interdisciplinary teams and Regulatory Affairs consultants to manage submission components and deliverables for all submissions.

Newport Beach, California, Us

Responsible for daily operations activities to prepare all US regulatory submissions, collaborating with interdisciplinary teams and Regulatory Affairs staff to manage submission components and deliverables for all submissions. Responsible for dispatching submissions to HC and US FDA through ESG Gateway.

Cambridge, Massachusetts, Us

Responsible for daily operations activities preparing all US regulatory submissions, and collaborating with the interdisciplinary teams and Regulatory Affairs consultants to manage submission components and deliverables for all submissions.

Responsible for daily operations activities preparing all US regulatory submissions, and collaborating with the interdisciplinary teams and Regulatory Affairs consultants to manage submission components and deliverables for all submissions.

Responsible for daily operations activities preparing all US regulatory submissions, and collaborating with the interdisciplinary teams and Regulatory Affairs consultants to manage submission components and deliverables for all submissions.

Cambridge, Ma, Us

Responsabile to daily operations activities for the preparation of global regulatory submissions, collaborating with interdisciplinary teams and Regulatory Affairs staff to manage submission components and deliverables for all submissions. Responsible for archiving all regulatory compliance documents. Primary system administrator for the day-to-day administration of Veeva RIM Vault

Boston, Ma, Us

Provides leadership within Regulatory Affairs and the development and implementation of Regulatory Operations strategies for many products for all WMA clients. Lead eCTD FDA publisher responsible for managing both the publishing and archiving functions as well as the dossier management functions in Regulatory Affairs.

Lead eCTD FDA publisher. Responsible for managing both the publishing and archiving functions as well as the dossier management functions for all their clients, including 510k, BLAs, NDAs, and INDs.

Lyon, Rhone, Fr

Responsible for evaluating, reviewing, and implementing new configurations for the document management system. Veeva RIM Business Administrator, Monitor alerts and troubleshoot critical production issues impacting end-users including system unavailability and data integrity issues. Oversee the implementation/training/delivery of Veeva RIM Vault application to meet business needs, improve business processes/efficiency, address process gaps and enable growth of the company. Manage, review, execute and maintain all Regulatory Operations systems and business process.

Durham, North Carolina, Us

Managed Paraxel’s clients’ worldwide health authorities submissions (electronic and paper) for multiple clients. Manage and supervise multiple teams that compiled and submitted pIND, ODD, IND, CTA, pNDA, NDA and BLA, Annual Reports, Clinical Study Reports (CSRs), SAEs. Established electronic submission capabilities, focusing on implementing the eCTD eCTDXpress. Supported and enforced compliance guidelines for global submission. Provided training to Global junior RA staff.

Supervised of formatting, publishing, compilation, and submission for all regulatory documentation to MAA, NDA and NDS and other international regulatory agencies. A key member of matrixed project teams, maintain submission-planning timelines for assigned submissions and implement submission strategies.

Cambridge, Ma, Us

Boston, Massachusetts, Us

Lead publisher for all EMA and Swiss Health submission. Worked closely with EU and Swiss teams to evaluate work in progress of all submission activities, including publishing, validation, and archival of all electronic submissions.

Worked as the publishing consultant for the Regulatory Operations department. Meet monthly face to face to review and strategized submission processes. Evaluated work in progress and performed routine and non-routine submission activities, including publishing, scheduling, scanning, submission compilation for paper and electronic submissions, and document archiving.

Horsham, Pa, Us

Troubleshoot and fixed format and style issues in MS Word documents to ensure ICH submission readiness standards for medical writers and other authors. Performed submission readiness activities including to all submission documents. Prepared MS word document to successfully change to .pdf format. Performed QC and bring up to ICH standard all .pdf documents, including adding intra-document hyperlinks and bookmarks, page rotation, and PDF optimization.

Verona, Vr, It

An integral member of the Global Regulatory Dossier Management Group. Managed clients activities associated with regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, overseeing publication activities, and utilizing a wide array of document management, authoring, and publishing tools. Managed Sharepoint for the archival of all submitted documents.

Charlestown, Ma, Us