工作职责：

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

任职资格：

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