Role Overview
This position serves as the Local Regulatory Responsible for Mexico, supporting regulatory compliance and product registration within the LATAM region and partner business networks. The role focuses on ensuring adherence to national health regulations for biological and biotechnological products, with responsibilities spanning product lifecycle management, labeling, batch release, and promotional material review.
Key Responsibilities
- Contribute to the development and execution of regulatory strategies for new product registrations and lifecycle changes in Mexico
- Track and communicate submission timelines, ensuring alignment with local requirements and corporate priorities
- Monitor updates in national regulations and industry practices to maintain ongoing compliance
- Manage registration projects for assigned products, including preparation and follow-up of variations and license renewals
- Ensure packaging and labeling meet country-specific standards and coordinate artwork approvals
- Facilitate batch release processes and support GMP inspection coordination
- Submit and maintain import permits for all relevant products
- Review and submit promotional content in line with local regulatory standards
- Maintain accurate records in global and local regulatory databases
- Support product inclusion in institutional tenders and healthcare system access initiatives
Qualifications and Experience
Candidates must hold a degree in life sciences such as Pharmacy, QFB, QFI, or IF, along with at least five years of experience in Mexican regulatory affairs. A solid grasp of local regulatory frameworks and procedures is essential.
Fluency in both Spanish and English is required, with strong written and verbal communication skills. Proficiency in MS Office applications is mandatory.
Experience with biologics, biotech products, or orphan drugs is highly valued. Familiarity with local health authority platforms such as DIGIPRIS and VUCEM is an advantage. Prior use of regulatory systems including Veeva, TrackWise, or GLAMS is also preferred.
Work Environment
This is a hybrid role based in Mexico, combining remote and onsite work. The schedule allows flexibility while ensuring effective collaboration with regional and global teams.
