Sarah Siqueira

At Abbott, I support end-to-end site start-up, from site identification through activation, while preparing and submitting CTA dossiers and amendments to FDA, ANVISA, and Ethics Committees.

I review and approve essential documents for ISF and TMF packages, customize PIS, ICF, and labels for local requirements, and use regulatory intelligence to identify risks before they delay activation. I work closely with investigators, sites, CRAs, feasibility, project management, and regulatory teams to keep critical-path timelines visible and on track.

Previously, I helped structure Hipolabor's first two product registrations and managed ANVISA registration, post-registration, and renewal dossiers across medicines, cosmetics, supplements, foods, and medical devices at Pharmascience and Belflar. My work spans CTD dossiers, CMC documentation, stability studies, analytical validations, supplier negotiations, due diligence, and regulatory strategy.

I'm committed to translating complex regulations into practical, compliant paths to study readiness and safe, swift market access. I also enjoy mentoring junior specialists and strengthening teams through clear processes and country-specific regulatory knowledge.