Job Title: Pharmaceutical Regulatory ExpertWe are seeking a highly skilled Pharmaceutical Regulatory Expert to lead the development and execution of regulatory strategies ensuring full compliance with national and international health regulations. This includes bioequivalent and bioavailability drugs, medical devices, controlled substances, and imported products. This individual will act as the key liaison with health authorities such as COFEPRIS, FDA, EMA, and international customs and regulatory entities. The role requires agile, safe, and legally sound access of products to the market. The successful candidate will design and implement regulatory strategies for product registration, importation, and lifecycle management. This includes coordinating dossier preparation and submission to relevant agencies, managing prior import permits, and overseeing documentation processes. The ideal candidate will have expertise in Mexican Official Standards (NOMs), ICH guidelines, and other applicable international regulations. Strong relationships with regulatory bodies, quality teams, and logistics partners are essential. A bachelor's degree in Pharmaceutical Chemistry, Biotechnology, Pharmacy, or related fields is required. A master's degree or specialization in Regulatory Affairs, Foreign Trade, or Health Legislation is preferred. The minimum experience required is 5–7 years in regulatory affairs within the pharmaceutical industry. Proven expertise in import procedures, prior permits, and customs regulation is necessary. Experience managing regulatory platforms and solid relationships with regulatory bodies are also required. The ideal candidate will possess comprehensive knowledge of national and international health regulations, familiarity with foreign trade laws, and regulatory handling of controlled substances. Advanced English language skills are essential, and a second language is a strong asset. Key Responsibilities: Design and implement regulatory strategies for product registration, importation, and lifecycle management Coordinate dossier preparation and submission to relevant agencies Manage prior import permits and oversee documentation processes Ensure compliance with Mexican Official Standards (NOMs) and ICH guidelines Collaborate closely with quality teams and logistics partners Represent the company before regulatory bodies Required Profile: Bachelor's degree in Pharmaceutical Chemistry, Biotechnology, Pharmacy, or related fields Preferred: Master's degree or specialization in Regulatory Affairs, Foreign Trade, or Health Legislation Minimum 5–7 years in regulatory affairs within the pharmaceutical industry Proven expertise in import procedures, prior permits, and customs regulation Solid relationships with regulatory bodies, quality teams, and logistics partners Benefits: Competitive compensation package Industry-leading benefits Why Us? We offer a dynamic work environment that values regulatory excellence. If you are passionate about shaping the future of healthcare, we encourage you to apply.
Job Title
Pharmaceutical Regulatory Expert