COLOMBIA BOGOTA BOGOTA D.C.

860001942

Bayer S.A.

TIEMPO COMPLETO

3 A 4 AÑOS

BACHILLERATO

Sí

Sí

1

30/01/2025

31/01/2025

Fabricación de productos farmacéuticos, sustancias químicas medicinales y productos botánicos de uso farmacéutico

NA

LaboreAccountable for the regulatory lifecycle management of products or assigned processes.
Responsible for Regulatory compliance of specific portfolio of products or assigned processes enabling business continuity. Ensure that marketed drugs are in conformance with local government guidelines and regulations.
Develop and implement regulatory strategies to support lifecycle activities (ie. submissions, renewals variations , deviations and amendments).
Prepares dossiers for submissions and amendments.
Ensures KPIs are achieved.
Supports and may lead operational excellence opportunities & projects.
Database update and maintenance.
Revision & Approval of Artworks.
Preparation, printing and submission of CMC, Labeling changes, advertisement, stock depletion to the Health Authority.
Define strategy, management and implementation of CMC, Labeling changes including major, minor submission to Health Authorities.
Compilate and negotiate with other stakeholders the needed activities to get timely dossiers, documents, samples to perform submissions, approvals and to guarantee RA ontime delivery to supplr supply or launches processes.
Lead process to request of samples, analytical standards, legal documents (CPPs, GMPs, legal declarations, statements, power of attorney etc) using Bayer Global tools in accordance to specific requirements and timelines of each country/process.
Request of legal translations and legalization internal and to external consultants.
Maintain timely updated assigned data bases.
Follow up submissions to ensure timely submission, approval and detect risk which could impact supply or compliance.
Responsible of the physical and electronical archive.
Support activities to make feasible the regulatory operation such as agreements, payments, purchase orders, reports and related activities.s relacionadas con el cargo solicitado en esta requisición, las anexas que se consideren convenientes ejecutar y las solicitadas específicamente por el representante de la supervisión patronal.