China Technical Regulatory – Policy Lead - CMC
About the job
- A degree in a relevant technical area such as Analytical, Biochemistry, Biology, or Pharmacy.
- At least 10 years of work experience in a relevant area, or a PhD in a relevant technical area combined with at least five years of work experience.
- Recognized expertise in a relevant CMC technical or regulatory area, with established external credibility as a thought leader.
- Ability to build and maintain strong relationships with global health authorities.
- In-depth knowledge of the China regulatory environment.
- Ability to operate successfully in a global matrix environment with shared accountability and responsibilities.
- Provide leadership, oversight, and execution of technical regulatory policy activities relevant to China for the Roche Pharma Group, including developing Roche policy positions on key Pharma Technical topics and advocating those positions externally.
- Collaborate with regulatory colleagues in China and globally to develop and execute the China regulatory policy roadmap.
- Ensure alignment and stakeholder engagement across Pharma Technical Operations, Product Development, Pharma International, governmental affairs, and external interest groups.
- Identify and enable regulatory policy activities in China to strengthen Roche’s standing with health authority agencies and industry peer groups, facilitating pipeline development, marketing authorizations, and manufacturing excellence.
- Build and maintain relationships with health authority professionals, academic and opinion leaders, and nonprofit scientific associations.
- Establish partnerships and networks with internal stakeholders in Regulatory, Technical, Quality, Medical, and Government Affairs, as well as external stakeholders.
- Ensure development, execution, and communication of the China regulatory policy roadmap.
- Lead cross-functional teams and regional or global regulatory communities of practice to drive policy change in China.
- Represent Roche’s technical regulatory policy views in China and beyond during external stakeholder engagement.
- Take leadership roles in local, regional, or global associations and governmental organizations in line with Roche positions.
- Provide leadership and consultancy to Roche Pharma Division leaders on regulatory policy and strategy topics affecting China.
- Act as a subject-matter expert for assigned technical regulatory policy and strategy areas, and lead development of specified Global Regulatory Policy positions in collaboration with subject-matter experts.
- Build influencing and advocacy knowledge and capacity, and empower colleagues to shape the regulatory environment.
- Previous experience in Regulatory, in industry or an agency, is preferred.
- Previous participation and proven effectiveness in international regulatory or industry forums is highly preferred.
About the company
Roche is a global leader in pharmaceuticals and diagnostics. It develops medicines and diagnostic tools that help detect, monitor, and treat diseases, using research and biotechnology to drive new therapies and tests. Roche combines drug development with in-house diagnostic products to support personalized medicine, where treatments are tailored to individual patients based on test results. Its approach differs from many peers by integrating drug discovery with diagnostic capabilities and by expanding its research through strategic acquisitions (like Genentech) to strengthen its biotechnology and R&D capabilities. The company’s goal is to improve patient outcomes and healthcare worldwide by delivering reliable medicines, accurate diagnostic tests, and data-driven care.
Company Size
1-10
Company Stage
IPO
Headquarters
Basel, Switzerland
Founded
1896
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Simplify's Take
What believers are saying
- Enicepatide delivered 15.5% weight loss in September 2026 and 22.7% in June.
- pTau217 can scale immediately through Roche's existing lab network and improve Alzheimer diagnostics.
- Roche's June 2026 data and September 2026 filings signal multiple obesity shots on goal.
What critics are saying
- Eli Lilly and Novo Nordisk dominate obesity pricing, distribution, and physician mindshare today.
- Enicepatide remains Phase II-only; Roche starts late-stage glycemic and cardiovascular studies in 2027.
- If enicepatide disappoints, Roche burns its $2.7 billion Carmot bet and loses obesity credibility.
What makes Roche unique
- Roche combines pharma, diagnostics, and installed cobas labs across 4,500 U.S. instruments.
- Elecsys pTau217 won FDA clearance on August 24, 2026, and CE marking September 7.
- Roche controls obesity assets from Carmot and Zealand, spanning GLP-1/GIP and amylin.
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Benefits
Performance Bonus
Company News
The US Food and Drug Administration has approved Roche's Tecentriq in combination with a fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III deficient DNA mismatch repair colon cancer. This marks Tecentriq's twelfth approved indication in the US. The approval follows the phase III ATOMIC study, published in The New England Journal of Medicine, which demonstrated that Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone. The 36-month disease-free survival rate was 86% with the combination versus 76% with chemotherapy alone. Nearly 25% of colon cancers are diagnosed at stage III, and almost one in three stage III patients experience recurrence within five years. This represents the first approved adjuvant immunotherapy regimen for this patient population. Roche is pursuing further regulatory filings, including with the European Medicines Agency.
Roche posted strong Phase 2 results for its weight loss drug enicepatide, showing 22.5% mean weight loss over 48 weeks. This compares favourably to Eli Lilly's Zepbound, which achieved 20.2% weight loss over 72 weeks in a separate trial. In another Phase 2 study, enicepatide demonstrated HbA1c reductions of up to 2.65 percentage points in diabetic patients after 48 weeks, compared to tirzepatide's 2.37 percentage points after 52 weeks. Despite promising results, Roche faces stiff competition from Novo Nordisk and Eli Lilly, which both have deep pipelines in development. Novo Nordisk's CagriSema is nearing approval, whilst Eli Lilly's retatrutide has posted strong Phase 3 results. Roche's revenue grew 6% year over year in the first half of the year to 30.4 billion Swiss francs.
Roche has launched a newborn screening test that simultaneously detects three severe genetic conditions: Spinal Muscular Atrophy, Severe Combined Immunodeficiency Disease, and Sickle Cell Disease. TIB MOLBIOL, a Roche subsidiary, developed the LightMix Newborn TREC/SMN1/HBB kit for use in countries accepting the CE mark. The test enables early detection before symptoms appear, allowing clinicians to initiate life-changing treatments sooner. Early intervention can prevent severe nerve damage in SMA, enable lifesaving bone marrow transplants for SCID, and drastically lower infant mortality in SCD through preventive measures. The IVDR-approved test provides a ready-to-use solution that integrates into existing laboratory workflows. It runs on established LightCycler systems, making it accessible for private and academic hospital laboratories across Europe.
Roche's collaborator MediLink has announced positive phase III results for tambotatug pelitecan (Tam-Peli) in Chinese patients with relapsed small-cell lung cancer. The TAISHAN-302 trial showed Tam-Peli reduced the risk of death by 54% compared to topotecan, with median overall survival of 13.3 versus 9.4 months. The antibody-drug conjugate also demonstrated superior progression-free survival (7.4 versus 2.8 months) and objective response rates (59.1% versus 9.7%). China's National Medical Products Administration has accepted the New Drug Application for filing. Roche is developing and commercialising Tam-Peli outside mainland China, Hong Kong and Macau, with plans to rapidly initiate global trials. The therapy has received Breakthrough Therapy Designations from both the US FDA and China CDE for relapsed small-cell lung cancer.
Tempus AI has raised $600 million in Series C funding to scale its machine learning platform for cancer recurrence detection through liquid biopsies. The investment was led by SoftBank Vision Fund 2, with participation from Roche and Merck. Phase II trial data showed the AI-enhanced liquid biopsy analysis reduced false-negative results by 37% compared to conventional methods. The platform uses deep learning algorithms trained on over 12,000 genomic profiles to identify circulating tumour DNA fragments shed by residual cancer cells. A 2025 Nature Medicine study reported the system achieved 92% specificity in detecting minimal residual disease across breast, lung, and colorectal cancers. According to SEC filings, 45% of funds will support FDA pre-market approval trials, whilst 30% will fund global expansion into EU and APAC markets.