Regulatory Affairs Manager

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 At Roche, we believe that securing and maintaining regulatory approval is the fundamental bridge between groundbreaking science and the patients who need it. Without regulatory success, patients cannot access our innovations. As a Regulatory Affairs Manager within our Competence Center Science, you will play a critical, mandatory role in ensuring full lifecycle management and maintaining regulatory approvals for all Roche products in Sweden. You will operate in full compliance with both national (Medical Products Agency / Läkemedelsverket) and EU legislation, bringing your strategic regulatory expertise to cross-functional teams and global stakeholders. Key Responsibilities In this role, your primary accountability is to secure and maintain regulatory approvals for medicinal products, medical devices, and In-Vitro Diagnostic (IVD) performance studies. Lifecycle Management: Manage and maintain Marketing Authorizations (MAs) for products registered via Centralized (CP), Mutual Recognition (MRP), and National Procedures (NP) in Sweden. Ensure timely implementation of submissions and post-approval changes in line with EU/national regulations and Roche internal standards. Clinical & Performance Studies: Oversee and manage regulatory submissions for Medical Devices and In-Vitro Diagnostic (IVD) performance studies to the Swedish Medical Products Agency (MPA). Artwork & Labeling: Manage and maintain artwork for medicinal products and medical devices. Review and approve labeling for Investigational Medicinal Products (IMPs). Compliance & SOPs: Establish, manage, and maintain Standard Operating Procedures (SOPs) and local work instructions for regulatory activities. Maintain up-to-date knowledge of national and corporate standards to drive continuous training. Global & HQ Support: Provide strategic input to Global HQ on national regulatory nuances, Scientific Advice procedures, and feedback on draft product information prior to EU submissions. Authority Engagement: Act as the primary point of contact for all direct communication with the Swedish Medical Products Agency (MPA) for your assigned product portfolio. Cross-Functional Collaboration: Partner closely with internal stakeholders—including Disease Area Teams, Clinical Operations, Governmental Affairs, and local Strategic Teams—to coordinate regulatory strategy, ensure alignment, and lead launch activities. Capabilities and Competencies Strategic Influence: Ability to communicate with impact, translate complex regulatory frameworks into actionable business advice, and elevate regulatory knowledge across the organization. Collaborative Leadership: Strong interpersonal skills with a proven track record of building cross-functional networks, driving decisions, and working effectively in matrix teams. Quality & Integrity: A mindset anchored in high quality, precision, operational integrity, and compliance. System Knowledge: Tech-savvy with comfortable navigation of regulatory management databases and submission portals. Qualifications & Experience Education: University degree in Pharmacy, Biomedicine, Life Sciences, or equivalent practical experience. Experience: Proven experience within the pharmaceutical industry, specifically in Regulatory Affairs. Regulatory Expertise: Thorough, working knowledge of Swedish (MPA) and EU regulatory frameworks, guidelines, and procedures. Language Skills: Professional fluency (both written and spoken) in Swedish and English is required. Competence Center: Science Location: Office-based (Stockholm, Sweden) Reports To: Head of Competence Center Science, Country Medical Director Direct Reports: N/A What We Offer You will join a purpose-driven environment where your work directly impacts patient access to life-changing treatments. Roche offers a collaborative culture, continuous learning opportunities, and the platform to grow your expertise across local and global networks. How to Apply If you are passionate about regulatory excellence and driven by our mission to transform healthcare, we welcome your application. Please submit your CV and cover letter via the Roche Careers Portal in English. 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.