Key responsibilities

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

CMC Regulatory Strategy and Change Management

1. 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.
2. Proactively identify documentation requirements and assess regulatory risks, enabling efficient submission planning and minimizing approval delays.
3. Lead regulatory evaluation of CMC changes and provide strategic guidance to project teams, ensuring robust change management and sustained product compliance.
4. Continuously refine regulatory strategies based on evolving project needs, regulatory feedback, and policy changes to support successful product development and lifecycle management.

Manufacturing and Testing Practice (MTP) Establishment

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

CMC Technical Assessment and Regulatory Support

Submission and Approval of Marketed Product Maintenance

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

Regulatory Compliance and System

Regulatory Compliance

Accept corporate compliance audit to identify potential compliance issues.
Take corrective actions plans based on regulatory audit findings.
Develop, update and implement appropriate SOPs.

Regulatory Tools

Be aware of the competitor information.
Skilled performance in using global regulatory system: LIFT, Vault RIM, NovoGlow, etc.

Regulatory Policy Influence and Advocacy

External

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

Internal

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

Cross Function/Department Supporting

Provide strategic regulatory input to cross-functional teams (e.g., PA, Medical Affairs), enabling compliant and effective business initiatives.
Support locally manufactured products by ensuring regulatory compliance across manufacturing and quality activities.
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

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today.

CMC Associate Manager