[Skip to main content](#main-content) [ OpenNash ](https://opennash.com/) / [Jobs](https://jobs.opennash.com/) [ 01 Search jobs](https://jobs.opennash.com/search/)[ 02 Companies](https://jobs.opennash.com/explore/)[ 03 Hiring report](https://jobs.opennash.com/reports/hiring/)[ 04 AI assistants](https://jobs.opennash.com/connect/)[ 05 How it works](https://jobs.opennash.com/methodology/) Roche Holding · Multiple locations # Director, Technical Regulatory Multiple locations Full-time Director Legal & Compliance Listed on Roche Holding’s official careers site. Posted October 21, 2026. Check that it is still open and apply there. [Apply on Roche Holding’s careers site →](https://roche.wd3.myworkdayjobs.com/roche-ext/job/Shanghai/Director--Technical-Regulatory_202610-125716) [OpenNash Jobs](https://jobs.opennash.com/) / [Roche Holding](https://jobs.opennash.com/companies/roche-holding/) / Director, Technical Regulatory ## Job description At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position ### Job Description Single point of contact for CMC topics and issues related to China submission for assigned products. Accountable for development, communication and execution of sound regulatory strategies for early stage CTA and life cycle management submissions that meet China regulatory requirements and enable business objectives. Identification and communication of regulatory risks and development and execution of risk mitigation strategies in concert with local and global teams. End to end manage early stage CTA and related submissions (CMC amendment, DSUR), including (but not limited to) lead CMC strategy discussion, dossier & documents preparation, submission, QnA, RIM, CTN etc. Lead response strategy to China Health Authority questions and support tracking of CMC commitments. Leading and/or coordinating health authority interactions for assigned projects. Ensuring up-to-date China regulatory requirements are maintained, communicated and integrated into project teams work plan, and proactively prepare for new requirements. Work together with PDR China Partner to ensure “One Regulatory Voice” in creating strategy and coordinating submission activities. Partner with China Policy to identify opportunities to shape the regulatory requirements around technical topics interested in Roche. Accountable for post approval CMC changes, NDA/BLA, CMC process build/improvement as appropriate. ### QUALIFICATIONS Education Degree in relevant technical areas (Analytical, Biochemistry, Biology, Pharmacy). Master Degree is preferred. ### Experience 8 or more years of work experience in the pharmaceutical industry. 5 or more years of CMC RA experience. Strong proven experience in Regulatory Affairs with focus on early stage CTA submission, and CMC requirements for small molecule/biologic products, development, manufacturing and/or quality experience. Technical background or experience of diverse modalities is a plus, e.g., ATMP, ADC, oligo, peptide. Global CTA submission (US, EU, Canada, South Korea, etc) experience is a plus. Knowledge/Skills/Competencies Demonstrates effective problem-solving ability, has a strong understanding of regulatory strategies, shows excellent interpersonal skills and has the ability to prioritize multiple tasks. Has proven ability to influence and work both independently and collaboratively in a team structure. Strong knowledge of ICH and China regulations and guidelines. Knowledge of EMA, FDA, Canada regulations and guidelines is a plus. Strong verbal and written communication skills. Fluent in English and Chinese. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. ## At a glance - Posted by the employer: Oct 21, 2026 - First seen by OpenNash: Oct 25, 2026 - Last checked: Nov 8, 2026 - Listed for: 18 days - Location: Multiple locations - Employment type: Full-time[Apply on Roche Holding’s careers site →](https://roche.wd3.myworkdayjobs.com/roche-ext/job/Shanghai/Director--Technical-Regulatory_202610-125716) ## Hiring at Roche Holding - Open jobs: 1,258 - New in the last 7 days: 216 - Tracked since: Jul 16, 2026 [All Roche Holding jobs](https://jobs.opennash.com/companies/roche-holding/) · [Weekly hiring report](/reports/hiring/) ## More jobs at Roche Holding ### [Global Supply Chain Process Architect – Planning & Regulatory Compliance](https://jobs.opennash.com/companies/roche-holding/jobs/3a84b3e347fcb651b868/) ### [Head of Compliance and Quality Governance](https://jobs.opennash.com/companies/roche-holding/jobs/fecbb6e6ddbf9fb96381/) ### [ERP Functional Consultant](https://jobs.opennash.com/companies/roche-holding/jobs/434905ef70926d91478e/) ### [ERP Test Manager (ASPIRE)](https://jobs.opennash.com/companies/roche-holding/jobs/bae73acdb36534712c68/) ### [Early Development Biometrics Lead](https://jobs.opennash.com/companies/roche-holding/jobs/0b0535f17436797dc474/) ## Similar jobs at other companies ### [Technical Regulatory Compliance Senior Technologist](https://jobs.opennash.com/companies/caterpillar/jobs/d8385ff1b90f574ef646/) Caterpillar ### [Technical and Regulatory Specialist](https://jobs.opennash.com/companies/veolia-environnement/jobs/dca0d6feaebfdc040dec/) Veolia Environnement · Ottawa, ON, Canada ### [Regulatory Reporting - Technical Architect - Assistant Vice President](https://jobs.opennash.com/companies/state-street/jobs/299c7b7968dc40122c8a/) State Street · Bangalore, India ### [Technical Regulatory Reporting Analyst](https://jobs.opennash.com/companies/hong-kong-exchanges/jobs/1e80fd7a36e626f501a8/) Hong Kong Exchanges · London, UK ### [Senior Manager, Regulatory Technical Authority](https://jobs.opennash.com/companies/venture-global/jobs/e083c6ec61843ae6f193/) Venture Global · Houston, Texas [Legal & Compliance jobs](/functions/legal-compliance/) OpenNash lists jobs from employers’ own careers sites and does not handle applications. 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