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

Role Fit Statement
This role is best suited for candidates who are comfortable with early-stage environments, system-building responsibilities, and who are qualified and willing to act as Responsable Sanitario.

At the early stage, regulatory execution will primarily be handled by CROs. The role therefore focuses on coordination, oversight, and regulatory judgment.
This position is not suitable for candidates whose experience is primarily centered on hands-on dossier writing or single-product execution roles.