Open to opportunities

Romina Sardi

@rominasardi

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Regulatory Affairs and Pharmacovigilance leader delivering LATAM approvals and efficient processes.

Argentina

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What I'm looking for

I want to lead Regulatory Affairs and Pharmacovigilance work across LATAM, driving efficient CTD/CMC submissions and strong QMS practices. I’m looking for a role where I can develop talent, manage priorities and budgets, and ensure compliant, high-quality regulatory outcomes.

I’m a regulatory affairs professional focused on Asuntos Regulatorios and Farmacovigilancia across LATAM. Currently, I lead the RA team (3 specialists) and plan strategic CTD/CMC registration work for company portfolio approvals in LATAM countries.

I bring experience in pharmacovigilance programs, promotional material review, and budget management, with an emphasis on creating efficient processes and developing talent. I manage RA & PV QMS, NC and CAPA, and oversee activities such as labeling planning and alignment with local regulatory requirements.

Previously, I advanced as Regulatory Affairs Manager South LATAM & Technical Director Deputy, coordinating submissions, renewals, and amendments, and managing QMS for medical devices and biological products. I also built strong foundations from earlier RA roles (dossier development in CTD format, post-registration variations) and quality control activities (stability studies and analysis), with Spanish as my native language and English at an advanced level.

Experience

Work history, roles, and key accomplishments

Current

Gerente de Asuntos Regulatorios

Current

Tecnonuclear S.A.

Oct 2023 - Present (2 years 9 months)

Led Regulatory Affairs and Pharmacovigilance efforts for medicinal products and medical devices across LATAM, including CTD/CMC expertise, promotional material review, and budget management. Also served as a team leader and co-technical director, overseeing RA/QMS, NC and CAPA, and pharmacovigilance processes.

Regulatory Affairs Pharmacovigilance (PV)CTD CMC Promotional Materials QMS Non Conformities CAPA Team Leadership Budget Management Adverse Events

Gerente de Asuntos Regulatorios

Abbott legacy St. Jude Medical Argentina S.A.

Oct 2020 - Sep 2023 (2 years 11 months)

Managed Regulatory Affairs for South LATAM and served as Co-Technical Director, leading portfolio strategic planning and RA team coordination across multiple countries. Handled licensing submissions and approvals, including budget management and RA/QA oversight (SGC, NC, CAPA).

Regulatory Affairs Team Leadership CTD CMC Budget Management Non Conformities CAPA ANMAT Ministry of Health Authorizations Adverse Events

Consultor de Asuntos Regulatorios

IPRAT S.R.L.

Jan 2019 - Oct 2020 (1 year 9 months)

Provided regulatory consulting work including CTD dossier development and support for commercialization authorizations and post-registration variations for medicinal products and biologicals. Also coordinated LATAM regulatory strategy/submission follow-up and supported QMS/regulatory activities for medical devices and related products.

Regulatory Affairs Consulting Commercialization Post Registration Variation QMS Adverse Events Pharmacovigilance

Directora Técnica y Responsable RA

Biotronik Argentina S.R.L.

Sep 2017 - Dec 2018 (1 year 3 months)

Directed technical and Regulatory Affairs/QA functions for the Southern Cone, leading strategic portfolio planning and RA team coordination. Managed ENACOM licensing, QMS processes (NC/CAPA), importation/release activities, and adverse-event/field-safety notification workflows.

Regulatory Affairs QA Management Strategic Planning Team Leadership ENACOM Licensing CAPA Adverse Events Budget Management

Regulatory Affairs Specialist

Medtronic Latin America Inc.

Nov 2015 - Aug 2017 (1 year 9 months)

Handled Regulatory Affairs activities including strategic planning for submissions, renewals, and amendments, plus promotional material review for the Argentina portfolio. Managed ENACOM licensing requirements.

Regulatory Affairs Strategic Planning Renewals Promotional Materials ENACOM Licensing

Analista de Asuntos Regulatorios

Panalab S.A. Argentina

Mar 2013 - Nov 2015 (2 years 8 months)

Prepared and updated national regulatory dossiers for medicinal specialties, dietary supplements, and cosmetics, including post-registration variations and GMP-related documentation. Developed and assessed CTD dossiers internationally for multiple countries.

CTD Post Registration Variation GMP Medical Specialties Dietary Supplements Cosmetics ANMAT

Analista de Control de Calidad

Laboratorio Laborit S.R.L.

Nov 2012 - Feb 2013 (3 months)

Performed quality control testing including physical-chemical analysis of raw materials, bulk, and finished products, and monitored stability study results. Conducted microbiological tests when required.

Stability Testing Microbiological Testing Quality Control

Analista de Registros LATAM

Laboratorios Richmond S.A.C.I.F.

Nov 2011 - Oct 2012 (11 months)

Developed and maintained CTD dossiers and supported post-registration assessment activities for drug products across LATAM. Managed special packaging request assemblies according to country requirements.

CTD Dossiers Post Registration Variation Packaging Assembly