Reporting directly to the China and Japan PO&T Lead, with a dotted-line functional relationship to Global Regulatory CMC, the China Regulatory CMC Lead serves as Biogen’s senior in-country Regulatory CMC leader and subject-matter expert for China. The role sets China CMC regulatory direction in alignment with Global Regulatory CMC, interprets evolving regulations, policies, guidelines, and health authority expectations, and translates them into enterprise-level strategies and practical decisions across development, registration, lifecycle management, business development, launch, and continuity of supply.
The role operates through strategic influence and a shared local–global delivery model. While this role will focus on local interpretation, strategic integration, prioritization, governance, and mutually agreed China-specific deliverables, the China Regulatory CMC Lead and Global Regulatory CMC will agree the allocation of responsibilities based on expertise, capacity, program needs, and business priorities. The role partners closely with the China Regulatory Affairs affiliate team.This role is expected to act as a PO&T leader in country helping to shape PO&T cross-functional priorities, resolve complex and high-impact issues, represent China in global governance, and provide informed advice to senior local and global leaders.
This role can be based in either Shanghai or Beijing.
Accountability Description
Set China Regulatory CMC strategy and provide authoritative local expertise(35%) Establish the China CMC regulatory vision and strategic direction across the portfolio; interpret laws, regulations, technical guidelines, pharmacopoeial requirements, and evolving CDE/NMPA expectations; anticipate external changes and their enterprise implications; advise senior local and global leaders on risk, opportunity, and investment choices; and lead or strategically direct health authority engagement on complex CMC topics in partnership with Regulatory Affairs and Global Regulatory CMC.
Lead the China portfolio through a shared local–global operating model(35%) Act as China Regulatory CMC Lead for assigned and emerging programs and products; define China regulatory pathways, critical assumptions, priorities, decision points, and integrated plans; and deliver selected high-value local activities, which may include China-specific content and input to the Quality Overall Summary (QOS) and Module 3, responses to questions, regulatory assessment and coordination of filing requirements and cross-functional dependencies associated with China local testing and QC transfers, change assessments, registration maintenance, and review of Chinese-language documents. Establish accountabilities, capacity-based work allocation, and decision rights with Global Regulatory CMC, the China Regulatory Affairs affiliate team, external partners, and vendors; sponsor fit-for-purpose external support where needed; and escalate systemic resource or portfolio risks. Global Regulatory CMC will continue to lead global strategy and core dossier activities and will partner with the China Regulatory CMC Lead to allocate work based on expertise, capacity, program needs, and business priorities, and ensure balance is achieved.
Shape regulatory intelligence, external engagement, and organizational capability(15%) Partner with Biogen Regulatory Intelligence Team with Regulatory Affairs and establish a forward-looking China CMC intelligence agenda; assess the strategic impact of emerging policy and regulatory trends across modalities and the portfolio; maintain senior-level relationships with CDE/NMPA and relevant industry associations as appropriate; represent and advance Biogen perspectives in external forums; and create scalable guidance, capability building, and ways of working that strengthen China readiness across local and global organizations.
Provide enterprise and cross-functional China PO&T leadership(15%) Serve as a China PO&T leader with responsibilities that…