
Timeline
About me
Regulatory Affairs Analyst at Viatris
Education

Universidad de costa rica ucr
-Pharmacy degree
Experience

Universidad de costa rica ucr
Mar 2017 - Jan 2018LAYAFA (Laboratorio de Análisis y Asesoría Farmacéutica) Physicochemistry assistant.
Quality Control Assistant
Mar 2017 - Jan 2018Teacher Assistant
Mar 2017 - Jul 2017

Bloom learn and teach
Jan 2018 - Jan 2019Tutor
Apatident
Mar 2018 - Jul 2022EntrepreneurCo-founder. ApatiDent is a start-up dedicated to the creation of cosmetic dental care products. As co-founder my rol in this start-up is directed to laboratory work as well as administrative work. Specifically I am in charge of stability tests and research studies.

Farmacia especializada los yoses
Jan 2019 - Jan 2019Community pharmacy internship
Universidad de costa rica ucr
Mar 2019 - Jan 2022INIFAR (Instituto de Investigaciones Farmacéuticas): Pharmacology department: THI neurological effects.
Organic Chemisty Assistant
Jan 2021 - Jan 2022General Chemistry Assistant
Mar 2019 - Jan 2022Research and Quality Assistant
Jul 2018 - Jan 2022Research and laboratory assistant
Mar 2019 - Jan 2019

Amazon
Jan 2020 - Jan 2021Seller and brand support representative
Sykes latam
Jan 2020 - Jul 2020Customer service representative bilingual
Asuntos regulatorios registrek s.a.
Jan 2022 - Jan 2023Regulatory Affairs Coordinator
Jun 2022 - Jan 2023Regulatory Affairs Intern
Jan 2022 - Jun 2022

Viatris
Jan 2023 - nowRegulatory affairs analystArtwork & Labeling Analyst for Central America and the Caribbean.-Support CA&C Markets in artwork updates, performing internal artworks change requests and evaluating their impact in every country depending on the regulation, creating strategies to submit and implement this changes. -Ensure compliance with all relevant company SOPs.-Coordinate RA activities in partnership with Quality and Supply to ensure that their packaging, product appearance and finished product specification comply with the regulatory approval.-Receive global triggers related to medicines safety and plan strategies with other teams for labeling submissions, so all region has the last and most updated information reported.-Analyze all CA&C regulations to perform submissions and resolve Health Authority queries and commitments received. -Liaise with the different Health Authorities to communicate the business needs to accomplish the access of quality medicines to patients.-Ensure a good communication and plan collaborative strategies with other teams to make sure all products are in full compliance and are being supplied correctly in every country, so every patient can access to their treatments. -Maintain all systems and information up to date according to the approved information in every country-Support projects, renewals, NDA, and different Post Approval changes dossier creation. Mostrar menos
Licenses & Certifications
- View certificate

Leading through inspiration
SkillsoftNov 2023 - View certificate

Saving time by setting goals
SkillsoftNov 2023 - View certificate

Análisis de datos con power bi 1
Universidad cenfotecJan 2023 - View certificate

Análisis de datos con power bi 2
Universidad cenfotecJan 2024
Languages
- spSpanish
- enEnglish
- poPortuguese
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