Compliance officer English Speaker (Ciudad de México)

Compliance officer English Speaker (Ciudad de México)

17 ago
|
Freyr Solutions
|
Ciudad de México

17 ago

Freyr Solutions

Ciudad de México

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 general 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 manag

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

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