Regulatory Affairs & Quality Coordinator
Regulatory Affairs & Quality Coordinator
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Purpose
Act as responsible for obtaining and maintaining Theramex product registrations and licenses in compliance with COFEPRIS regulations while collaborating closely with global and regional teams to ensure the integration of local needs into broader strategies and maintain the highest standards of quality and regulatory practice.
Key Duties and Responsibilities
The following key activities from a regulatory perspective:
- Proactively seek information and opportunities that can accelerate review and approval timelines
- Map and influence key internal and external stakeholders to streamline regulatory pathways
- Build and maintain strong relationships with external regulatory bodies such as COFEPRIS industry associations and other relevant authorities
- Dossier management and post-approval maintenance
- Submission of applications response to technical requirements and scheduling meetings with authorities
- Maintenance of applicable operational licenses
- Provide expert regulatory advice and ensure strategic alignment with global and local business goals
- Interpret and enforce relevant standards and operating procedures addressing complex technical regulatory issues
- Oversee project management and execution of all phases of the regulatory lifecycle
- Coordinate the distribution and tracking of documentation related to product registration and commercialization in Mexico
- Lead regulatory evaluations to determine product classification and licensing requirements
- Drive new regulatory projects to expand the product portfolio
- Support the oversight of the local Marketing Authorization Holder
- Oversee the preparation of regulatory policy reports
- Review marketing materials to ensure compliance with regulatory requirements
- Provide training on regulatory aspects including product information procedures and best practices for storage and distribution
The following key activities from a quality perspective:
- Maintaining a compliant Quality Management System (including POPs) for Theramex Mexico and support the integration into Theramex global QMS
- Ensure Theramex Mexico maintains compliance with its licences and COFEPRIS regulations
- Manage the Technical Responsible
- Support the management and oversight of local suppliers (3PL / QC lab) and batch release process
- Work with the HQ team to support the product quality complaint process for Theramex Mexico
- Deliver quality training to the local team and be responsible the training Tool in Mexico
- Improve training competences in the training tool
- Manage clients qualification
- Support and Carry out quality control actions for pharmaceutical products and services
Minimum Requirements (experience & education)
- 5 years in Pharma industry
- Large experience of working in Regulatory Affairs at International Pharmaceutical industry
- Previous experience in Pharmacovigilance is a plus
- Deep understanding of the current regulatory environment
- Good listener and communication skills
- Fluency in English
- Pharmacy Graduated education
- Post-graduation or equivalent is a plus
Employment Type
Full Time
