Regulatory Affairs

azelis· Azelis Mexico
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📍 Mexico City - Via Gustavo BazFull time

About this role

Experience

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 (Official Mexican Standards). • Experience with technical-regulatory documentation: CPP (Certificate of Pharmaceutical Product), 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 escalate risks in a timely manner.

Qualifications

• Experience in the distribution of specialty chemicals, pharmaceutical raw materials, APIs, or excipients. • Experience in Pharma, Food & Nutrition, Personal Care, or related sectors. • Knowledge of tariff codes (HS codes), NICO codes, and non-tariff regulations. • Experience working with Foreign Trade and Customs Brokers. • Knowledge of SADER and SENASICA regulations. • Experience with regulated substances and inventory reconciliation/drawdowns. • Knowledge of nitrosamines, elemental impurities, residual solvents, TSE/BSE, GMOs, and allergens. • Experience with D365, SAP, or other ERP systems. • Proficiency with Power BI or regulatory databases. • Experience with regulatory audits or CAPA tracking. • Prior contact with international manufacturers or Principals.

Education

Degree in Pharmaceutical Chemistry (QFB), Pharmacy, Chemistry, Chemical Engineering, or a related field.

Frequently Asked Questions

Is the salary disclosed for the Regulatory Affairs position at azelis?
The salary for this Regulatory Affairs role at azelis is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs position at azelis located?
This Regulatory Affairs role at azelis is based in Mexico City - Via Gustavo Baz. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs role at azelis full-time or part-time?
This is listed as a Full time position. It is posted as a Regulatory Affairs role in the Azelis Mexico department at azelis.
Which team or department does the Regulatory Affairs at azelis belong to?
This Regulatory Affairs position is part of the Azelis Mexico department at azelis. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Regulatory Affairs position at azelis?
Click the "Apply Now" button on this page. You will be redirected to azelis's official application portal hosted on workday where you can submit your application directly.
When was the Regulatory Affairs job at azelis posted?
This Regulatory Affairs position at azelis was posted on Sep 15, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs
azelis
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You'll be redirected to azelis's official application page on Workday.