Regulatory Affairs Specialist

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

Your Opportunity

As a key member of our Regulatory Affairs team, you will be at the forefront of bringing innovative medical solutions to the market. You will drive the registration process for life-changing products, ensuring full compliance with NMPA regulations while strategically influencing the future of industry standards.

Key Responsibilities:

• Strategic Registration Management: Lead the preparation, submission, and tracking of registration dossiers to ensure timely approvals in line with business forecasts.

• Regulatory Influence & Advocacy: Actively participate in the formulation of national/industrial standards and guidelines, providing feedback to authorities that aligns with global regulatory strategies.

• Quality & Compliance Excellence: Guarantee the absolute accuracy and truthfulness of all dossiers; maintain rigorous documentation in IT systems (SharePoint, V-drive) in accordance with SOPs and SHE (Safety, Health, and Environment) duties.

• Stakeholder & Network Building: Establish and maintain high-level relationships with NMPA testing centers, key contacts, and internal cross-functional teams (CO/CCOE) to accelerate product launches.

• Risk Mitigation & Innovation: Proactively identify regulatory risks across the product lifecycle, develop robust mitigation plans, and propose innovative registration strategies to optimize resources and timelines.

• Cross-Functional Collaboration: Provide expert regulatory support to internal departments and manage stakeholder expectations regarding budgets, compliance, and project milestones.

Who You Are

You are a proactive, detail-oriented regulatory professional who thrives on complexity and is passionate about healthcare innovation. You combine technical expertise with the interpersonal savvy needed to navigate a rigorous regulatory landscape.

Qualifications & Experience:

• Education: Bachelor’s degree or above in Medicine, Bioengineering, Clinical Medicine, Biochemistry, or Pharmacy.

• Professional Experience: At least 5 years of experience in Medical Regulatory Affairs. Background in IVD (In Vitro Diagnostics) R&D or IVD regulatory affairs is highly preferred.

• Regulatory Expertise: Deep knowledge of NMPA regulations, policies, and standards. Experience in drafting PTRs and managing QC type testing is a plus.

• Language & Tech: Fluent in English (listening, speaking, reading, and writing) and highly proficient in MS Office.

Core Competencies:

• Strategic Thinker: Ability to independenty handle risk assessments and figure out innovative registration strategies to shorten time-to-market.

• Resilient Communicator: Excellent negotiation and interpersonal skills; comfortable working under pressure and challenging the status quo to drive optimization.

• Collaborative Mindset: A team player who demonstrates the Roche values of Integrity, Courage, and Passion, with a commitment to self-starting and independent problem-solving.

• Detail-Oriented: A disciplined approach to filing, record-keeping, and ensuring the integrity of complex data sets.

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.