Especialista de Asuntos Regulatorios

Descripción del puesto:

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 distribution.
* Follow up on inserts versions approved by manufacturing and receiving country
* Upload dossier for submission and validate its visualization in DARIUS
* Upload Dossier submitted to the different affiliates and validated visualization in Darius
* verify the correct filling of the information in DARIUS (Creation of activities, Compile Dossier in National Section, Updating Submission and approval dates, Uploading Approval letters).
* Check that all products of the Regulatory Plan are listed in DARIUS.
* Verify that all new products have Planisware Number (ATOM/RAPTOR)
* Keep Abbott's regulatory databases current as assigned.
* Review of SI report of CFR products.
* Support and train the affiliates for TPM Dossiers on DARIUS system.
* Support on the creation of LLCR for CCDS/RL updates for all TPMs
* Review and assure the maintenance of the marketing status of the products on DARIUS.
* Ensure that the different global reports have a response in the agreed times, as well as that those items that require updating are made in the Abbott systems (Monthly highlights, Submissions and approvals, rejections, Validity report, Monthly tracking report, SIR-AMP.)
* Coordinate the support on DARIUS problems and trainings with the global team.
* Leader and create the reports for the local labelling updates for CFR products.
* Compilate the information of global request (RSI, WWMAS)
* Update constantly the Spreadsheet of LATAM products.
* Coordinate and ensure the updating of the CTD for each affiliate, ensuring that it meets the requirements of each one.
* Ensure the update of the RADIUS system.
* Prepare reports to be reviewed by the TPMs team and regional RA leads

Required Qualifications
* Pharmacist, Chemical Engineer, Microbiologist, or related science fields.

Preferred Qualifications
* Experience requirement: 2- to 4-years' experience
* English Level: Intermediate
* Management of computer systems. (Power BI desirable)

Apply Now

* Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
* Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Regulatory Operations

DIVISION:
EPD Established Pharma

LOCATION:
Colombia > Bogota D.C. : Calle 110 No 9 - 25

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
No

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Not Applicable