Summary
Overview
Work History
Education
Skills
Personal Information
Timeline
Generic
Tania Morales

Tania Morales

Biochemical Engineer
Mexico City

Summary

Biochemical engineer with 6-year experience in the regulatory field working with government authorities (COFEPRIS, SADER / SENASICA, SEMARNAT, PROFECO). Focused in leading regulatory processes, specialized in regulatory compliance and the documentation necessary to ensure the conformity and approval of products in LATAM region.

Overview

6
6
years of professional experience
4
4
years of post-secondary education

Work History

Regulatory Affairs Specialist - MEXICO

Hill's Pet Nutrition de México S.A. de C.V.
03.2022 - Current
  • Fully responsible and representative for Mexico's regulatory processes for a 150+ product portfolio as the main market for the business.
  • Timely preparation, presentation and adequate monitoring of new Registrations and maintenance of current portfolio among Renewals and Modification applications on corresponding authority (SADER / SENASICA).
  • Strategy implemented to increase a 60% of product portfolio with new registration approvals in a 2-year timeline.
  • Application of automation (AI) with internal resources to agile submissions and dossier assembles and winner of the "You Can Make A Difference" Colgate Program with this project.
  • Label Review and approval support to Global Team trough BEAT Software to accomplish corresponding KPI's for a specific launch in Mexico.
  • Establishment and maintenance of SOP's (Standard Operating Procedures) with current regulatory processes in Mexico to ensure legislation accomplish and legal corporate processes.
  • Attendance on SADER Annual Audit on regulatory documentation and warehouse conditions.
  • Attendance on PROFECO's studies, managing all necessary evidence to place the brand as a Premium Pet Food in the market and with the consumers.
  • Collaborated with cross-functional teams to develop risk mitigation strategies, reducing potential non-compliance issues.
  • Mexico's Regulatory Team Leader with 2 direct reports (Analyst and Intern).

Regulatory Affairs Specialist - CASACA

Hill's Pet Nutrition de México S.A. de C.V.
03.2022 - 06.2023
  • Responsible for all regulatory processes for pet food in Central America, Caribbean, and South America countries (Bolivia, Colombia, Costa Rica, Chile, Dominican Republic, Honduras, Guatemala, El Salvador, Panama, Paraguay, Peru, and Uruguay).
  • Daily communication and management of distributors in the region for regulatory follow-ups, mainly in the veterinary field, to ensure timeliness.
  • Analyze the causes of real or potential delays, and identify opportunities to improve timings.
  • Review of marketing materials before release to verify claims were regulatory supported, minimizing potential legal risks.
  • Maintenance of detailed records of all regulatory activities, enabling quick access during inspections or audits.

Regulatory Affairs Responsible

Lanxess S.A. de C.V.
06.2021 - 03.2022
  • Responsible for regulatory processes for biocides, medical devices, animal and human health products, mainly disinfectants in Mexico and Central American countries, including the Dominican Republic, Trinidad y Tobago, Ecuador, and Peru, in the Material Protection Products Business Line.
  • Close work with regulatory authorities in Mexico, COFEPRIS, SEMARNAT, SADER, and participation in work groups (ANIQ) to push regulatory improvements in the industry.
  • Prioritized project-related tasks to efficiently complete essential tasks.
  • Management of distributors in LATAM regions to ensure registrations and on-time approvals.
  • Preparation and maintenance of document inventory for core dossier preparation.
  • Regulatory Project Management - Regional Regulation Databases.
  • Approval of import licenses in Mexico, to ensure stock in the warehouse in a timely manner.
  • Review and approval of final product labels, according to each country's regulations.
  • Review of marketing material to align and ensure correct information with current regulations in each country.
  • Monthly report to regulatory global HQ in France and Germany, accordingly.

Regulatory Affairs and Internal Marketing Analyst

Lanxess S.A. de C.V.
07.2019 - 06.2021
  • Support on dossiers assembles and submissions for products within the company portfolio in compliance with corporate standards and local regulatory requirements in Mexico.
  • Responsible for local and global databases and systems update.
  • Generation and modification of labels according to local regulations.
  • Management of quotations and shelf life extension for biocide products from Germany, USA, Singapore, and India for Mexico, Central America, and the Andean region.
  • Update and monitoring of customer complaints in global database.
  • Support on supply chain management and customer service.

Education

Engineer - Biochemical Engineering

Instituto Politécnico Nacional
03.2015 - 07.2019

Skills

  • Microsoft 360
  • Google Tools
  • High Adaptability
  • Global regulatory compliance
  • International regulations
  • Regulatory training
  • Project management
  • Risk management
  • Impact assessment
  • Strategic planning

Personal Information

  • Date of Birth: 02/28/93
  • Marital Status: Single
  • Place of Birth: Mexico City

Timeline

Regulatory Affairs Specialist - MEXICO

Hill's Pet Nutrition de México S.A. de C.V.
03.2022 - Current

Regulatory Affairs Specialist - CASACA

Hill's Pet Nutrition de México S.A. de C.V.
03.2022 - 06.2023

Regulatory Affairs Responsible

Lanxess S.A. de C.V.
06.2021 - 03.2022

Regulatory Affairs and Internal Marketing Analyst

Lanxess S.A. de C.V.
07.2019 - 06.2021

Engineer - Biochemical Engineering

Instituto Politécnico Nacional
03.2015 - 07.2019

Similar Profiles

CREATE PROFILE
Tania MoralesBiochemical Engineer