Regional 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 PositionThe Opportunity The role will support the Regional Regulatory providing support on any regulatory affairs matters required for commercial operations. Main Responsibilities - End-to-End Premarket & Postmarket Registrations: Prepare, compile, and submit high-quality regulatory dossier packages for new product launches, line extensions, and renewals to ensure seamless market access and continuous product availability across the region. - Agency Engagement & Advocacy: Directly interact and negotiate with health authorities and regulatory bodies to secure rapid, optimal product clearances, approvals, and regulatory maintenance. - Commercial & Tender Enablement: Partner closely with Marketing, Product Management, Sales, and Logistics to provide required regulatory documentation (certificates, declarations) to support commercial tenders and business contracts. - Lifecycle & Change Management: Evaluate product, labeling, and manufacturing changes for regulatory impact, submitting change notifications and updating local control/tracking systems in compliance with regional standards. - Cross-Functional Advisory & Capacity Building: Act as the internal Subject Matter Expert (SME) to educate cross-functional teams, advise senior leadership on critical regulatory trends, and review/approve promotional materials for compliance. - Quality, Safety & Postmarket Compliance: Collaborate with Product Quality and Safety leads to fulfill adverse event reporting, recall management requirements, and support internal and external audit activities. - Process Optimization & Regional Governance: Continuously assess and refine internal regulatory processes, tracking tools, and regional network communications to align local practices with evolving regional regulations. Who you are Required experience and competencies - A minimum of 3 years of experience in regulatory - within medtech industry is a plus - Experience in project management and the ability to manage multiple priorities in a fast-paced environment. - Familiarity with regulatory policy frameworks and a keen interest in staying updated with global regulatory trends is a plus - Strong analytical skills and the ability to interpret complex regulatory information. - Ability to collaborate seamlessly across multi-disciplinary teams and drive shared business objectives - Excellent communication skills, both written and verbal, with proficiency in creating clear and compelling presentations. Who we areA 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.