China Regulatory CMC Lead

Job description

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. 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 extend beyond Regulatory CMC, including shaping cross-functional priorities, leading governance discussions, resolving issues across functions and regions, and establishing clear ownership and escalation paths while supporting PO&T initiatives and goals. Connect China requirements and business needs across Quality, Supply Chain, Technical Development, Manufacturing, Global Trade, Regulatory Affairs, Commercial, and other functions, and represent China priorities and trade-offs in global and regional forums. For Regulatory CMC-related matters, ensure filing impacts and cross-functional dependencies are identified and coordinated, while Quality/QC and the relevant technical functions retain ownership of technical transfer, laboratory readiness, validation or verification, testing execution, and data integrity.Leads matrix teams within a product program cross functionally or at global level.  May also drive product initiatives. Requirements Bachelor’s degree in pharmacy, chemistry, biochemistry, biology, engineering, or a related scientific discipline; advanced scientific degree preferred. Typically 12+ years of progressively responsible Regulatory CMC or closely related pharmaceutical development experience, including substantial China-specific experience, demonstrated work with CDE/NMPA/Shanghai MPA, and leadership of complex or high-impact regulatory matters across multiple programs or products. Proven experience setting CMC regulatory strategy, influencing senior governance, and leading execution across development, registration, post-approval change, and marketed-product lifecycle activities in a complex global matrix; prior people management is not required, but demonstrated leadership through influence is essential. Demonstrated Regulatory CMC leadership across small molecules, large molecules/biologics, antisense oligonucleotides (ASO), device, and drug–device combination products, with the judgment to integrate modality-specific considerations, challenge assumptions, and mobilize appropriate global experts. Job Level: Management Why Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.