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.
Skills Required
- 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, Regulation on Health Supplies, and applicable NOMs
- Experience with CPP, DMF, regulatory declarations, and technical dossiers
- Experience working with imported products
- Functional technical English
- Intermediate Excel skills
- Strong organizational, follow-up, risk escalation, and multitasking skills
- Experience in specialty chemicals, pharmaceutical raw materials, APIs, or excipients distribution
- Experience in Pharma, Food and 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 or 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
- Degree in Pharmaceutical Chemistry, Pharmacy, Chemistry, Chemical Engineering, or a related field
What We Do
As a leading global innovation service provider in the specialty chemicals and food ingredients industry, we are committed to creating value for principals and customers whilst providing a great work environment and career opportunities. Azelis has 4,200+ employees across 65 countries worldwide. We work with around 2,800 principals to provide a diverse range of innovative products/services to 63,000+ customers. Our industry-dedicated sales teams have specialist product and application knowledge, combined with business know-how, enabling us to add value in all business relationships. We’re always looking to add new talent to our team and encourage and support the personal and professional growth of all employees. Specialties include: Life Sciences: Personal Care, Home Care & Industrial Cleaning, Pharma & Healthcare, Food & Nutrition, Animal Nutrition, Agricultural & Environmental Industrial Chemicals: CASE, Electronics, Essential Chemicals, Fine Chemicals, Advanced Materials & Additives, Chemicals, Lubricants & Metal Working Fluids, Other Applications, Textiles, Leather & Paper At Azelis, our partnerships with customers and principals remain at the heart of our activities. As a leading global innovation service provider, our entrepreneurial approach to doing business is reflected in our can-do attitude. Across our network of more than 70 application laboratories, our award-winning staff help develop formulations and provide technical guidance along the customers’ product development process. We combine a global market reach with a local footprint to offer a reliable, integrated and unique digital service to customers and attractive business opportunities to principals. Striving to create a positive impact on the environment and communities around the world, we are top-industry-rated by Sustainalytics. Azelis is a leader in sustainability. We aim to provide effective, sustainable, and reliable solutions. Our business is your business
