Regulatory Affairs

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.