Key responsibilities <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">CMC Regulatory Strategy and Change Management</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Manufacturing and Testing Practice (MTP) Establishment</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">CMC Technical Assessment and Regulatory Support</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Submission and Approval of Marketed Product Maintenance</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Regulatory Compliance and System</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Regulatory Policy Influence and Advocacy</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Cross Function/Department Supporting</li> </ul> Main job tasks <ol style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">CMC Regulatory Strategy and Change Management</li> </ol> <ol style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="list-style:none;margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px"> <ol style="list-style-type:lower-alpha;margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">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.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Proactively identify documentation requirements and assess regulatory risks, enabling efficient submission planning and minimizing approval delays.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Lead regulatory evaluation of CMC changes and provide strategic guidance to project teams, ensuring robust change management and sustained product compliance.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Continuously refine regulatory strategies based on evolving project needs, regulatory feedback, and policy changes to support successful product development and lifecycle management.</li> </ol> </li> </ol> <ol style="margin-top:0.0cm;margin-bottom:0.0cm" start="2"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Manufacturing and Testing Practice (MTP) Establishment</li> </ol> <ol style="list-style-type:lower-alpha;margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 17.2px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Lead the establishment and lifecycle management of Manufacturing and Testing Practices (MTPs), ensuring alignment with global standards and local regulatory requirements.</li> <li style="margin:0.0cm 0.0cm 0.0cm 17.2px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Drive cross-functional and cross-regional alignment (NN HQ, STJ, China RA, and health authorities) to achieve efficient MTP preparation and regulatory acceptance.</li> <li style="margin:0.0cm 0.0cm 0.0cm 17.2px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Ensure high-quality and timely preparation of MTP documentation for CTA and NDA submissions, supporting successful regulatory approvals.</li> <li style="margin:0.0cm 0.0cm 0.0cm 17.2px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Maintain robust MTP governance, including document review, version control, and archive management, to ensure inspection readiness and regulatory compliance.</li> </ol> <ol style="margin-top:0.0cm;margin-bottom:0.0cm" start="3"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">CMC Technical Assessment and Regulatory Support</li> </ol> <ol style="margin-top:3.0pt;margin-bottom:1.0 E-4pt" start="2"> <li style="list-style:none;margin:3.0pt 14.35pt 1.0 E-4pt 0.0px;text-align:justify;line-height:125%;text-indent:10.0px"> <ol style="list-style-type:lower-alpha;margin-top:3.0pt;margin-bottom:1.0 E-4pt"> <li style="margin:3.0pt 14.35pt 1.0 E-4pt 0.0px;text-align:justify;line-height:125%;text-indent:10.0px">Own the management and maintenance of CMC regulatory documentation, ensuring consistency, traceability, and compliance across all submissions.</li> <li style="margin:3.0pt 14.35pt 1.0 E-4pt 0.0px;text-align:justify;line-height:125%;text-indent:10.0px">Lead the preparation of critical CMC documents and responses to health authority queries, enabling efficient resolution of regulatory questions and minimizing approval timelines.</li> <li style="margin:3.0pt 14.35pt 1.0 E-4pt 0.0px;text-align:justify;line-height:125%;text-indent:10.0px">Provide expert-level CMC technical support to project teams, driving resolution of complex regulatory and technical challenges.</li> <li style="margin:3.0pt 14.35pt 1.0 E-4pt 0.0px;text-align:justify;line-height:125%;text-indent:10.0px">Monitor and interpret regulatory trends and requirements, translating insights into actionable strategies to enhance submission quality and efficiency.</li> <li style="margin:3.0pt 14.35pt 1.0 E-4pt 0.0px;text-align:justify;line-height:125%;text-indent:10.0px">Contribute to regulatory advocacy initiatives by providing scientific and technical input, supporting favorable policy development and regulatory outcomes.</li> <li style="margin:3.0pt 14.35pt 1.0 E-4pt 0.0px;text-align:justify;line-height:125%;text-indent:10.0px">Strengthen organizational capability by delivering CMC training and developing guidance materials, enhancing overall regulatory competence within the team.</li> </ol> </li> </ol> <ol style="margin-top:0.0cm;margin-bottom:0.0cm" start="4"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:9.8px">Submission and Approval of Marketed Product Maintenance</li> </ol> <ol style="list-style-type:lower-alpha;margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Ensure compliant and efficient lifecycle maintenance of marketed products, including variations, renewals, labeling updates, and deregistration activities.</li> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Drive timely submission and approval of post-approval changes to support uninterrupted product supply and business continuity.</li> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Maintain effective communication with health authorities and internal stakeholders to facilitate smooth approval processes and alignment across functions.</li> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Ensure accurate documentation, archiving, and tracking of regulatory submissions and approvals.</li> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Support labeling and packaging compliance, ensuring alignment with regulatory requirements and business objectives.</li> </ol> <ol style="margin-top:0.0cm;margin-bottom:0.0cm" start="5"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Regulatory Compliance and System</li> </ol> <ol style="list-style-type:lower-alpha;margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Regulatory Compliance</li> </ol> <ol style="list-style-type:lower-roman;margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 34.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Accept corporate compliance audit to identify potential compliance issues.</li> <li style="margin:0.0cm 0.0cm 0.0cm 34.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Take corrective actions plans based on regulatory audit findings.</li> <li style="margin:0.0cm 0.0cm 0.0cm 34.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Develop, update and implement appropriate SOPs.</li> </ol> <ol style="list-style-type:lower-alpha;margin-top:0.0cm;margin-bottom:0.0cm" start="2"> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Regulatory Tools</li> </ol> <ol style="list-style-type:lower-roman;margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 34.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Be aware of the competitor information.</li> <li style="margin:0.0cm 0.0cm 0.0cm 34.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Skilled performance in using global regulatory system: LIFT, Vault RIM, NovoGlow, etc.</li> </ol> <ol style="margin-top:0.0cm;margin-bottom:0.0cm" start="6"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Regulatory Policy Influence and Advocacy</li> </ol> External <ol style="list-style-type:lower-alpha;margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;text-align:justify;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Establish and maintain strong relationships with health authorities and key stakeholders, contributing to efficient communication and positive regulatory outcomes.</li> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;text-align:justify;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Monitor regulatory environment changes and proactively assess their impact on business and product strategy.</li> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Lead or contribute to regulatory advocacy activities, influencing policy development to support business objectives and industry advancement.</li> </ol> Internal <ol style="list-style-type:lower-alpha;margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Act as a regulatory partner to cross-functional teams by providing insights on global regulatory status and local regulatory trends.</li> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Drive awareness of regulatory value within the organization, ensuring regulatory strategy is integrated into business decision-making.</li> </ol> <ol style="margin-top:0.0cm;margin-bottom:0.0cm" start="7"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Cross Function/Department Supporting</li> </ol> <ol style="list-style-type:lower-alpha;margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Provide strategic regulatory input to cross-functional teams (e.g., PA, Medical Affairs), enabling compliant and effective business initiatives.</li> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Support locally manufactured products by ensuring regulatory compliance across manufacturing and quality activities.</li> <li style="margin:0.0cm 0.0cm 0.0cm 10.0px;line-height:125%;Apis For Office', sans-serif;text-indent:10.0px">Review promotional and communication materials to ensure alignment with approved labeling and regulatory requirements, minimizing compliance risks.</li> </ol> Other areas of responsibility <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Industry association activities relevant to CMC issues</li> <li style="margin:0.0cm 0.0cm 2.0pt 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">HA engagement relevant to CMC issues.</li> </ul> Qualifications <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Relevant graduate level degree, e.g. Pharmacy, Pharmacology, Biology.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Fluency in both written & spoken English.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Min 3+ years’ experience in RA / CMC area in pharmaceutical industry.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">CMC relevant experience is preferred.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">PHD in biologics is preferred.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Strong understanding of Chinese and global regulatory frameworks</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Solid project management skills</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Strong teamwork and knowledge-sharing capabilities</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Ability to manage multiple tasks and priorities effectively</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Excellent verbal and written communication and interpersonal skills</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Strong conflict resolution, initiative, and negotiation skills</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Effective communication skills with internal stakeholders</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Strong analytical skills with high attention to accuracy and reliability</li> <li style="margin:0.0cm 0.0cm 2.0pt 0.0px;line-height:14.0pt;Apis For Office', sans-serif;text-indent:4.9333px">Creative thinking and problem-solving abilities</li> </ul> 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 (Beijing, Beijing, CN) @ novonord

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