Abbott

Healthcare

EspecialistadeAsuntosRegulatorios

$75000–110000k ~AI est. Bogota, Colombia FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Especialista de Asuntos Regulatorios at Abbott. Skills: Regulatory operations, Dossier management, Database updates. Consolidate reports from affiliates. Include global plan updates”

Industry & Context.

Healthcare

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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