Abbott
Healthcare
EspecialistadeAsuntosRegulatorios
“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
Applying for this Especialista de Asuntos Regulatorios role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Abbott?
Real rants from real employees. Read before you apply.