15 ago
|
Freyr Solutions
|
México
15 ago
Freyr Solutions
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 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
Role Overview
The RA Specialist is responsible for all aspects of regulatory submissions in the assigned markets. 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 is responsible for all regulatory submission requirements for their assigned product portfolio as applicable. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations as well as company SOPs.
Key Responsibilities
Assist in development of product registration plans & strategies and working cross-functionally to align & communicate the submission plans.
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 con
📌 Regulatory Affairs Specialist (México)
🏢 Freyr Solutions
📍 México