Regulatory Affairs Associate

Encontrado en: Talent CO C2 - hace 2 semanas


Cali, Colombia Colgate-Palmolive A tiempo completo

No Relocation Assistance Offered
# 159300 - Cali, Valle del Cauca, Colombia

The Regulatory Affairs Associate is responsible to support the implementation of regulatory strategies for the commercialization and regulatory compliance of products in Colombia, according to the local, regional and LatAm business plans, as well as the maintenance of product compliance during the whole life-cycle. The role provides support for the registration of local and imported products in the Andean Region countries and those others that import products from CP Cali manufacturing site.


Key Responsibilities

Preparation of dossiers and submission according to Colgate Palmolive standards to ensure local and imported products registration and life-cycle maintenance at INVIMA. Working cross-functionally with internal stakeholders at regional and local level to ensure business objectives are met through strong regulatory strategy and partnership. Proactively identifying regulatory requirements and risks for product categories (medical devices, cosmetics and household products), and developing plans for regulatory submissions and products compliance.  Review of artworks and other delivered documents to ensure regulatory product compliance through the different systems of the company. Preparation of the core dossier and support to the registration of the local and imported products in Andean Region -Bolivia, Ecuador and Peru - and also for those countries that import products from CP Cali manufacturing site. Work closely with the LatAm Regulatory Team to receive the appropriate dossier requirements support, and provide the projects status update and needed registration data for labeling and LatAm strategies. Supporting the responses to regulatory assessments and elaborate regulatory alerts concerning Colombia. Support and backup in trade association activities. Update and maintain registration and other databases, so tracking tools.


Experience and qualifications

BS degree in Pharmaceutical Chemistry Minimum of 2 years of regulatory affairs experience in the cosmetic or pharmaceutical industry with a track record of successful submissions. Experience with medical devices is desirable. Minimal supervision to execute tasks in a timely manner Attention to detail and sense of urgency, able to prioritize tasks Excellent communication and organizational skills Solid interpersonal and relationship-building skills Ability to collaborate with multiple stakeholders both internally and externally. Effective regulatory writing skills Fluent in English Excellent digital literacy, which includes working with databases, software, MS Office applications and Google applications/tools.

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