TANIA MORALES
Biochemical Engineer
Mexico City
Summary
Biochemical engineer with experience in leading regulatory processes, specialized in regulatory compliance and the documentation necessary to ensure the conformity and approval of products in LATAM region.
Overview
5
5
years of professional experience
4
4
years of post-secondary education
Work History
Regulatory Affairs Specialist - MEXICO
Hill's Pet Nutrition de México
Ciudad De México
3 2022 - Current
- Fully responsible and representative for Mexico's regulatory processes for a 100+ product portfolio.
- Management of all local regulatory submissions from starch.
- Close work with regulatory authority (SADER - SENASICA) for follow-ups and to bring to their attention main timelines, projects, and evaluate plans to improve times.
- Evaluate new business opportunities from a regulatory perspective, providing valuable insight into potential challenges or benefits.
- Collaborate with cross-functional teams to develop risk mitigation strategies, reducing potential non-compliance issues.
- Streamline internal processes for timely submission of regulatory documentation to authorities (learning and application of AI and DOMO Software).
- Stay updated on changing regulations by attending industry conferences and maintaining professional expertise in the field (e.g.). Foro Mascotas, Feed Latina, CONAFAB monthly meetings.
- Establish strong relationships with global regulatory counterparts (NORAM, ASIA-PAC, EU), facilitating efficient information exchange and collaboration.
- Approval on SADER Annual Audit, with positive comments from authority regarding regulatory management and warehouse accommodations.
- 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.
- Regulatory support during a recall/market withdrawal activities as necessary.
- Conducted risk assessments to identify potential areas of non-compliance, implementing corrective actions as needed.
- Monthly report to the Regulatory Manager, located in Brazil, on Mexico's processes, approvals, marketing plans, and contingency plans for delays.
Regulatory Affairs Specialist - CASACA
Hill's Pet Nutrition de México
Ciudad De México
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.
- Elaboration and maintenance of SOPs for all countries, considering different regulations.
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's Degree - Biochemical Engineering
Escuela Nacional De Ciencias Biológicas (ENCB), Instituto Politécnico Nacional
Ciudad De México 03.2015 - 07.2019
Skills
Management of: Microsoft 360, Google Tools (100%), Visionpoint, Stibo Systems, Veeva, SAP, Lotus Notes
Advanced English language (90%)
High Adaptability
Teamwork
Proactive
Search for Integral solutions
High sense of responsibility
Availability to travel
Regulatory Policies
Project and Risk Management
Technical Documentation
Personal Information
- Place of Birth: Mexico City
- Date of Birth: 02/28/93
- Marital Status: Single
Timeline
Regulatory Affairs Specialist - CASACA
Hill's Pet Nutrition de México
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's Degree - Biochemical Engineering
Escuela Nacional De Ciencias Biológicas (ENCB), Instituto Politécnico Nacional
03.2015 - 07.2019
Regulatory Affairs Specialist - MEXICO
Hill's Pet Nutrition de México
3 2022 - Current
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