About Freyr Freyr Solutions is a leading global Regulatory Solutions and Services company supporting Life Sciences organizations across pharmaceuticals, biologics, medical devices, and consumer healthcare industries. Freyr partners with integral clients to deliver specialized regulatory, compliance, and operational support across worldwide markets.

Job Title: Regulatory Affairs Specialist Location: Mexico - Remote Employment Type: Full-Time/Indefinite Critical to this role is to combine knowledge of scientific, and regulatory issues to enable new/established products that are developed, manufactured, or distributed meet the local legislations and company procedures. Leveraging on expertise in regional regulations, Authority expectations and industry trends, this role will collaborate closely with cross-functional teams to enhance regulatory initiatives, drive regulatory compliance, and support supply continuity. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations as well as company SOPs.

Support maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications, site transfers, importation, distribution, tender related activities and supplemental marketing authorizations in accordance with local regulations and global standards. # Maintain and archive regulatory documents in accordance with department and company policies and local requirements. # Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.



# Assists in improving local procedures (in compliance with regional and global standards) for the department, to ensure quality RA data and evaluates processes for potential improvement in efficiency and effectiveness. # May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with Quality and supply chain to avoid supply constraints and ensure constant audit-readiness. # Agency requests with post-marketing samples # Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed. Monitor regulatory trends, drives compliance, and proactively manages and mitigates risks to achieve quality outcomes. Ability to work in partnership with others (internally and externally) to accomplish quality goals; leads integrated projects and build effective networks.

Ability to effectively negotiate and influence management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met. Minimum of 5 years of industry experience in regulatory affairs and/or CMC. Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.

The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken). . Opportunity to work with global pharmaceutical clients. Opportunity to work on high-impact global regulatory projects.

At Freyr

Solutions , you will work alongside industry experts supporting complex global regulatory programs for leading Life Sciences organizations. Freyr offers an opportunity to contribute to critical regulatory and CMC initiatives while building expertise in global pharmaceutical compliance and submission standards.

📌 Compliance officer English Speaker (México)
🏢 Freyr Solutions
📍 México