Regulatory Affairs Specialist – Mexico (COFEPRIS)

Azelis Holding S.A.; Estado de México; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

Azelis is seeking a Regulatory Affairs professional with 2–4 years of experience to support compliance activities across life sciences and industrial chemicals. You will work on COFEPRIS procedures, import permits, and regulatory dossiers, collaborating with international manufacturers and brokers to ensure timely compliance and documentation.

The role requires knowledge of health regulations, exposure to SAP/D365, and a strong attention to detail.

Formación

• 2 to 4 years of experience in Regulatory Affairs, Regulatory Quality, or a similar role.
• Direct experience with COFEPRIS procedures.
• Experience with sanitary import permits, renewals, extensions, and validity tracking.
• Knowledge of General Health Law, Regulation on Health Supplies, and NOMs.
• Experience with CPP, DMF, regulatory declarations, and dossiers.
• Experience with Foreign Trade and Customs Brokers.
• Knowledge of SADER and SENASICA regulations.
• Experience with regulated substances and inventory reconciliation/drawdowns.
• Prior contact with international manufacturers.

Conocimientos

Strong organizational skills

Follow-up capabilities

Attention to detail

Ability to manage multiple procedures

Technical English proficiency

Educación

Degree in Pharmaceutical Chemistry (QFB)

Herramientas

D365

SAP

Power BI

Descripción del empleo

Azelis is seeking a Regulatory Affairs professional with 2–4 years of experience to support compliance activities across life sciences and industrial chemicals. You will work on COFEPRIS procedures, import permits, and regulatory dossiers, collaborating with international manufacturers and brokers to ensure timely compliance and documentation.

The role requires knowledge of health regulations, exposure to SAP/D365, and a strong attention to detail.