CMC Associate Manager

• CMC Regulatory Strategy and Change Management
• Manufacturing and Testing Practice (MTP) Establishment
• CMC Technical Assessment and Regulatory Support
• Submission and Approval of Marketed Product Maintenance
• Regulatory Compliance and System
• Regulatory Policy Influence and Advocacy
• Cross Function/Department Supporting

 Main job tasks

1. CMC Regulatory Strategy and Change Management
2. Facilitate the development and execution of phase-appropriate CMC regulatory strategies for China submissions, ensuring timely approvals and alignment with both global strategy and local regulatory expectations.
3. Proactively identify documentation requirements and assess regulatory risks, enabling efficient submission planning and minimizing approval delays.
4. Lead regulatory evaluation of CMC changes and provide strategic guidance to project teams, ensuring robust change management and sustained product compliance.
5. Continuously refine regulatory strategies based on evolving project needs, regulatory feedback, and policy changes to support successful product development and lifecycle management.

1. Manufacturing and Testing Practice (MTP) Establishment
2. Lead the establishment and lifecycle management of Manufacturing and Testing Practices (MTPs), ensuring alignment with global standards and local regulatory requirements.
3. Drive cross-functional and cross-regional alignment (NN HQ, STJ, China RA, and health authorities) to achieve efficient MTP preparation and regulatory acceptance.
4. Ensure high-quality and timely preparation of MTP documentation for CTA and NDA submissions, supporting successful regulatory approvals.
5. Maintain robust MTP governance, including document review, version control, and archive management, to ensure inspection readiness and regulatory compliance.

1. CMC Technical Assessment and Regulatory Support
2. Own the management and maintenance of CMC regulatory documentation, ensuring consistency, traceability, and compliance across all submissions.
3. Lead the preparation of critical CMC documents and responses to health authority queries, enabling efficient resolution of regulatory questions and minimizing approval timelines.
4. Provide expert-level CMC technical support to project teams, driving resolution of complex regulatory and technical challenges.
5. Monitor and interpret regulatory trends and requirements, translating insights into actionable strategies to enhance submission quality and efficiency.
6. Contribute to regulatory advocacy initiatives by providing scientific and technical input, supporting favorable policy development and regulatory outcomes.
7. Strengthen organizational capability by delivering CMC training and developing guidance materials, enhancing overall regulatory competence within the team.

1. Submission and Approval of Marketed Product Maintenance
2. Ensure compliant and efficient lifecycle maintenance of marketed products, including variations, renewals, labeling updates, and deregistration activities.
3. Drive timely submission and approval of post-approval changes to support uninterrupted product supply and business continuity.
4. Maintain effective communication with health authorities and internal stakeholders to facilitate smooth approval processes and alignment across functions.
5. Ensure accurate documentation, archiving, and tracking of regulatory submissions and approvals.
6. Support labeling and packaging compliance, ensuring alignment with regulatory requirements and business objectives.

1. Regulatory Compliance and System
2. Regulatory Compliance
3. Accept corporate compliance audit to identify potential compliance issues.
4. Take corrective actions plans based on regulatory audit findings.
5. Develop, update and implement appropriate SOPs.
6. Regulatory Tools
7. Be aware of the competitor information.
8. Skilled performance in using global regulatory system: LIFT, Vault RIM, NovoGlow, etc.

1. Regulatory Policy Influence and Advocacy

External

1. Establish and maintain strong relationships with health authorities and key stakeholders, contributing to efficient communication and positive regulatory outcomes.
2. Monitor regulatory environment changes and proactively assess their impact on business and product strategy.
3. Lead or contribute to regulatory advocacy activities, influencing policy development to support business objectives and industry advancement.

Internal

1. Act as a regulatory partner to cross-functional teams by providing insights on global regulatory status and local regulatory trends.
2. Drive awareness of regulatory value within the organization, ensuring regulatory strategy is integrated into business decision-making.

1. Cross Function/Department Supporting
2. Provide strategic regulatory input to cross-functional teams (e.g., PA, Medical Affairs), enabling compliant and effective business initiatives.
3. Support locally manufactured products by ensuring regulatory compliance across manufacturing and quality activities.
4. Review promotional and communication materials to ensure alignment with approved labeling and regulatory requirements, minimizing compliance risks.

Other areas of responsibility

• Industry association activities relevant to CMC issues
• HA engagement relevant to CMC issues.

Qualifications

• Relevant graduate level degree, e.g. Pharmacy, Pharmacology, Biology.
• Fluency in both written & spoken English.
• Min 3+ years experience in RA / CMC area in pharmaceutical industry.
• CMC relevant experience is preferred.
• PHD in biologics is preferred.
• Strong understanding of Chinese and global regulatory frameworks
• Solid project management skills
• Strong teamwork and knowledge-sharing capabilities
• Ability to manage multiple tasks and priorities effectively
• Excellent verbal and written communication and interpersonal skills
• Strong conflict resolution, initiative, and negotiation skills
• Effective communication skills with internal stakeholders
• Strong analytical skills with high attention to accuracy and reliability
• Creative thinking and problem-solving abilities