Regulatory Affairs Specialist - 858

In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM.

• Provide guidance and support about Mexican and Central America legislation
• Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
• Contribute to the production of client administrative documents to be included in regulatory submissions
• Compile regulatory dossiers in accordance with national requirements.
• Systems Management and Administration
• Document and track regulatory submissions and regulatory authority approval.
• Provide regulatory support to clients and associate companies
• Liaise with sponsor head-office and affiliate departments on regulatory issues.
• Provide review of packaging texts.
• Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
• Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

• Bachelor’s degree or more in a Life Sciences related field. Pharmacy degree would be a plus.
• 5+ years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider