Regulatory Affairs Specialist – COFEPRIS & Dossiers

Azelis; Ciudad de México; Presencial; MXN 450.000 - 750.000; Jornada completa

Descripción de la vacante

Azelis is seeking a Regulatory Affairs professional in Mexico City to manage regulatory quality tasks for imported products. You will liaise with manufacturers, prepare regulatory submissions, and track permits and compliance across COFEPRIS guidelines, NOMs, and related regulations.

The role requires 2–4 years in regulatory roles, English reading proficiency, and strong organizational skills to handle multiple procedures with timely risk escalation.

Formación

• 2 to 4 years of experience in Regulatory Affairs, Regulatory Quality, or a similar role.
• Direct experience with COFEPRIS procedures.
• Proficiency with VUCEM and/or DIGIPRiS.
• Experience with sanitary import permits, renewals, extensions, and validity tracking.
• Practical knowledge of the General Health Law, the Regulation on Health Supplies, and applicable NOMs.
• Experience with technical-regulatory documentation: CPP, DMF, regulatory declarations, and dossiers.
• Experience working with imported products.
• Functional technical English for reading documentation and communicating with manufacturers.
• Intermediate Excel skills.
• Strong organizational skills, follow-up capabilities, and attention to detail.
• Ability to manage multiple procedures simultaneously and escalating risks in a timely manner.

Conocimientos

Regulatory affairs

Excel

Power BI

Documentation management

Attention to detail

Educación

Pharmaceutical Chemistry (QFB)

Pharmacy

Chemistry

Chemical Engineering

Herramientas

D365

SAP

ERP systems

Regulatory databases

Descripción del empleo

Azelis is seeking a Regulatory Affairs professional in Mexico City to manage regulatory quality tasks for imported products. You will liaise with manufacturers, prepare regulatory submissions, and track permits and compliance across COFEPRIS guidelines, NOMs, and related regulations.

The role requires 2–4 years in regulatory roles, English reading proficiency, and strong organizational skills to handle multiple procedures with timely risk escalation.