Abbott
Healthcare
EspecialistadeAsuntosRegulatorios
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Especialista de Asuntos Regulatorios at Abbott. Skills: Regulatory operations, Dossier management, Database updates. Consolidate reports from affiliates. Include global plan updates”
Industry & Context.
What They're Looking For.
Must Have
Pharmacist, Chemical Engineer, Microbiologist, or related science fields
Nice to Have
2- to 4-years’ experience, Intermediate English Level, Power BI desirable
What You'll Do.
Consolidate reports from affiliates
Include global plan updates
Request modules from QA
Update RA database plan
Upload change control activities
Remind activity owners to close change control
Notify deviations to due dates
Follow up on risk assessment updates
Follow up on approved inserts versions
Upload dossier for submission
Validate dossier visualization in DARIUS
Upload submitted dossier to affiliates
Validate visualization in Darius
Verify correct information filling in DARIUS
Create activities in DARIUS
Compile Dossier in National Section
Update submission and approval dates
Upload approval letters
Check products in Regulatory Plan
Verify new products have Planisware Number
Keep regulatory databases current
Review SI report of CFR products
Support affiliates for TPM Dossiers
Train affiliates on DARIUS system
Support creation of LLCR
Review maintenance of marketing status
Ensure global reports have response
Update items in Abbott systems
Coordinate DARIUS problems support
Coordinate DARIUS trainings
Create reports for local labelling updates
Compile global request information
Update LATAM products spreadsheet
Coordinate CTD update for each affiliate
Ensure CTD meets requirements
Ensure RADIUS system update
Prepare reports for TPMs team
Prepare reports for regional RA leads
How You'll Work.
Team & Collaboration
Regional teams; RA Leaders; QA, clinical and TPMs; Global team; TPMs team; Regional RA leads
Full Job Description
## **JOB DESCRIPTION:** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **** **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: * Career development with an international company where you can grow the career you dream of . * A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists This position works out of our Bogotá location in the Established Pharmaceuticals division. We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory. **What You’ll Do** * Receive data by affiliates to consolidate reports to regional teams. * Include updates for global plan in the template based on information received by RA Leaders * Follow up to other areas QA, clinical and TPMs to request the different modules to ensure dossier can be prepared by the RA Specialists * Follow up and keep the RA database 2024 plan updated according to the approvals or submissions reported by the affiliates. * Ensure change controls have activities uploaded in the system and activities owners received a reminder to close the change control. * Notify deviations to different due dates * Follow up to indications updates in the risk assessment for labeling distribu
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