Mexico Regulatory Affairs Director(J14731)

1. Regulatory & Compliance System Setup (Core Responsibility) • Build a scalable regulatory and compliance management system from the ground up, including but not limited to: • Regulatory SOPs and internal workflows • Registration project management tools (timelines, trackers, risk logs) • CRO governance and management mechanisms • Ensure the company is organizationally and procedurally prepared to act as a registration holder 2. CRO Registration Project Coordination and Management • Act as the company’s internal regulatory project owner, overseeing registration activities executed by external CROs • Be responsible for and maintain control over: • Overall registration strategies and pathways for generic drugs and biosimilars • Registration timelines and submission sequencing • Review and coordination of deficiency responses prior to submission or regulatory authority interaction • Exercise independent professional judgment over CRO deliverables, rather than serving solely as an administrative coordinator At the current stage, hands-on preparation of regulatory dossiers or drafting of technical documents is not required. 3. Regulatory Authority Communication and Compliance Judgment • Coordinate and, when necessary, participate in registration-related communications with COFEPRIS • Provide internal regulatory and compliance assessments, including: • Evaluation of CRO registration strategies, timelines, and regulatory positions • Ensure all registration activities align with applicable Mexican regulations and practical enforcement expectations 4. Multi-Product Registration Planning and System Scalability Preparation • Support the company’s product pipeline planning by: • Designing overall timelines for multiple parallel registrations • Preparing internal systems in advance for increased registration volume and complexity • Lay a structural foundation for potential future internalization of regulatory execution 5. Responsable Sanitario (Mandatory Requirement) • Formally act as and be registered with COFEPRIS as the company’s Responsable Sanitario, in compliance with Mexican sanitary regulations • Fulfill the corresponding sanitary and compliance responsibilities required of pharmaceutical companies and registration holders under applicable laws and regulations

Mandatory Requirements • Mexican nationality • Relevant educational background in pharmacy or related fields • Fluent in English; able to use English as a working language • 6–10 years of experience in pharmaceutical regulatory affairs or related compliance roles • Strong familiarity with COFEPRIS registration processes, particularly for generic drugs and/or biosimilars • Proven experience managing CROs or external regulatory service providers • Legally qualified and willing to act as Responsable Sanitario Preferred Qualifications • Experience covering both generic drugs and biosimilars • Experience in early-stage subsidiary or new business setup • Experience managing multiple registration projects in parallel • Prior participation in NMC-related processes is a strong plus 现在申请 返回职位列表 收藏 热招职位 更多 >> 省区副总经理（四川）(J14703) SNJ自营地区经理（四川）(J14754) 自营地区经理（浙江）(J13577) 省区副总经理（陕西）(J14369) 省区副总经理（浙江）(J14637) 长招职位 更多 >> 招商地区经理（海口）(J14149) ©2026  科兴制药 京ICP备05051632号-16 京公网安备 11010802032024号 隐私政策 Powered by