Regulatory Affairs Associate | Fixed-term contract

REGULATORY AFFAIRS ASSOCIATE | FIXED-TERM CONTRACT Roche ABOUT THIS OPPORTUNITY At Roche, you'll join a global organization dedicated to advancing science and ensuring healthcare access for generations to come. We value authentic expression, open communication, and genuine connections that allow you to thrive professionally while making a meaningful impact on global health. With over 100,000 employees worldwide, Roche has treated more than 26 million people and conducted over 30 billion diagnostic tests. Here, every voice matters and contributes to our mission of preventing, stopping, and curing diseases. THE ROLE As a Regulatory Affairs Associate, you will provide essential operational support to the Drug Regulatory Affairs Lead while driving regulatory submissions across the Roche East Africa affiliate. You'll manage the complete lifecycle of post-marketing variations, safety submissions, and product renewals while ensuring data integrity across Roche's Global Regulatory Information Management Systems (RIMS). Your Key Responsibilities Regulatory Submissions & Strategy Execute the affiliate's regulatory strategy by collaborating with internal stakeholders to ensure product registrations meet business timelines. You'll prepare, review, and file high-quality regulatory applications with local Health Authorities to secure timely product approvals. Lifecycle & Compliance Management Maintain uninterrupted product supply by proactively managing post-approval activities including variations, safety labeling updates, GMP renewals, and registration renewals. You'll maintain real-time accuracy in RIMS, log submission and approval metrics, and monitor the local regulatory landscape for guideline changes that impact the portfolio. Additionally, you'll serve as backup Qualified Person for Pharmacovigilance. Cross-Functional Collaboration Partner across Medical, Commercial, Pharmacovigilance, and Quality departments to provide regulatory insights supporting business continuity. You'll support the DRA Lead in building transparent, professional relationships with health authorities and industry bodies while communicating regulatory updates to global teams. WHAT YOU BRING Education & Credentials You hold a Bachelor of Pharmacy (B.Pharm) degree with valid registration from the Pharmacy and Poisons Board (PPB), Kenya. Experience You bring 2 to 3 years of hands-on regulatory affairs experience in a multinational pharmaceutical company or specialized life sciences organization. Core Competencies You're a self-motivated individual with meticulous attention to detail who translates concepts into compliant outcomes with minimal supervision. You excel at managing multiple complex portfolios simultaneously while dynamically prioritizing tasks to meet strict deadlines. Your exceptional written and verbal English communication skills enable you to navigate health authority networks and cross-functional teams effectively. You approach compliance challenges with strong analytical thinking and collaborative problem-solving aligned with affiliate objectives. Above all, you maintain high ethical standards and strict adherence to corporate compliance, local regulations, and industry codes of conduct. Roche is an Equal Opportunity Employer.