[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 · Sant Cugat del Vallès # Regulatory Affairs Specialist Sant Cugat del Vallès Full-time Legal & Compliance Listed on Roche Holding’s official careers site. Posted November 5, 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/Sant-Cugat-del-Valls/Regulatory-Affairs-Specialist_202610-127991-1) [OpenNash Jobs](https://jobs.opennash.com/) / [Roche Holding](https://jobs.opennash.com/companies/roche-holding/) / Regulatory Affairs Specialist ## 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 A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. As a Regulatory Affairs Specialist, you will partner closely with cross-functional internal teams and external stakeholders to bring life-changing diagnostic solutions to market. In this role, you will prepare high-impact submission dossiers for Health Authority approvals and champion agile principles to drive regulatory milestones within our Oncology In-vitro Diagnostics (IVD) team. ### What You Will Do Regulatory Submissions & Strategy: Lead and coordinate the preparation of registration dossiers for products and programs of moderate complexity. Formulate sound regulatory submission plans to secure market access globally. ### Health Authority & Compliance Frameworks Apply knowledge of global regulations (e.g., IVDR, FDA, ISO 13485) to establish robust regulatory pathways that keep Roche products legally and ethically compliant. ### Stakeholder Partnership & Audits Cultivate enduring, collaborative relationships with internal partners and external regulatory bodies. Actively contribute to inspection and audit readiness, execution, and corrective actions. ### Problem-Solving & Innovation Work with autonomy to identify operational bottlenecks and propose practical, forward-looking solutions. Champion continuous improvement and explore new digital tools or automated workflows to drive efficiency. ### VACC Leadership & Agile Mindset Embody the spirit of “We all lead” through the VACC model (Visionary, Architect, Catalyst, Coach). Act with integrity, courage, and passion while fostering an inclusive, high-trust team environment. ### Who You Are You are someone who wants to influence your own development. You are looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point. ### Required Qualifications & Experience Education: University degree (Bachelor’s or Master’s) in Life Sciences, Biotechnology, Biomedical Engineering, Data Science, or a related field (or equivalent practical experience). ### Professional Experience 1+ years of relevant experience within Regulatory Affairs, Quality Assurance, R&D, or Clinical Operations in healthcare or life sciences. ### Digital & IT Fluency Proficiency in MS Office and Electronic Document Management Systems (EDMS/RIMS). ### Communication Fluency in English (both written and spoken), with the ability to communicate regulatory concepts clearly across diverse teams. ### Preferred / Nice-to-Have Hands-on experience with IVD (In-vitro Diagnostics) or Medical Device regulations (EU IVDR 2017/746, US FDA 510(k)/PMA, etc.). Exposure to process automation, robotic workflows (RPA), or AI-enabled regulatory tools. Familiarity with international quality standards (e.g., ISO 13485). 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: Nov 5, 2026 - First seen by OpenNash: Nov 8, 2026 - Last checked: Nov 8, 2026 - Listed for: 3 days - Location: Sant Cugat del Vallès - Employment type: Full-time[Apply on Roche Holding’s careers site →](https://roche.wd3.myworkdayjobs.com/roche-ext/job/Sant-Cugat-del-Valls/Regulatory-Affairs-Specialist_202610-127991-1) ## 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 ### [Risk & Governance Intern](https://jobs.opennash.com/companies/roche-holding/jobs/881b297385896343b2d3/) Sant Cugat del Vallès ### [Senior Backend Engineer (Python / FastAPI) Scrum Master](https://jobs.opennash.com/companies/roche-holding/jobs/b65194fdcc97fa4c5aab/) Sant Cugat del Vallès ### [Senior Business Architect](https://jobs.opennash.com/companies/roche-holding/jobs/6381301ba896719c8d07/) Sant Cugat del Vallès ### [Senior Cybersecurity Analyst](https://jobs.opennash.com/companies/roche-holding/jobs/567672ff7f1cdfbb7527/) Sant Cugat del Vallès ### [Senior Process & Transformation Manager - Direct Procurement](https://jobs.opennash.com/companies/roche-holding/jobs/65c5a2348dd32b18901b/) Sant Cugat del Vallès ## Similar jobs at other companies ### [Regulatory Affairs Manager, Oncology Therapeutic Group, Global Regulatory Affairs](https://jobs.opennash.com/companies/gsk/jobs/09fdd8d7e12226e3ad65/) GSK · London, United Kingdom ### [Associate-Global Regulatory Affairs-Regulatory Delivery & Excellence-Regional Regulatory Associate](https://jobs.opennash.com/companies/eli-lilly/jobs/71835fd7e5e1c00b290d/) Eli Lilly · Petaling Jaya, Selangor, Malaysia ### [Senior Regulatory Specialist I - Toxicology, Global Regulatory Affairs](https://jobs.opennash.com/companies/ecolab/jobs/a7f265c77c592a38c347/) Ecolab · Pune, Mahārāshtra, India ### [Regulatory Affairs Specialist](https://jobs.opennash.com/companies/ecolab/jobs/2f207cd244cb549328ab/) Ecolab · Kraków, Poland ### [Principal Regulatory Affairs Professional](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/3a8ef8a0559f4968a312/) Thermo Fisher Scientific · Remote, Mexico [Legal & Compliance jobs](/functions/legal-compliance/) OpenNash lists jobs from employers’ own careers sites and does not handle applications. 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