PTR Regulatory Program 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 As a Regulatory Program Manager , you will join the Regulatory Centralization Team to broaden your understanding of the regulatory landscape and execute key deliverables aligned with our strategic vision . In this role, you will be responsible for the submission of high-quality CMC regulatory documents globally in accordance with cGMP, Roche corporate standards, and health authority requirements. Acting as a key contributor to technical regulatory team outcomes, you will ensure full regulatory compliance, data accuracy, and the timely approval of Roche products across their lifecycle. The Opportunity Ensure the submission of high-quality CMC regulatory documents to health authorities globally according to cGMP, Roche corporate standards, and applicable regulatory requirements. Maintain direct accountability for the compliance and accuracy of data in regulatory documents and Regulatory Information Management (RIM) systems. Ensure cross-functional PTR deliverables are completed compliantly, accurately, thoroughly, and in a high-quality, timely manner to support product approvals. Contribute to technical regulatory team outcomes, regulatory excellence, risk mitigation, and continuous improvement of departmental business processes. Understand the structure, key roles, and responsibilities of local and international regulators, global health authority regulations, and ICH guidelines. Drive faster access to Roche products through optimal regulatory pathways, reliance, and convergence across global markets. Ensure overall excellence in regulatory compliance throughout the complete product lifecycle. Who you are Bachelor’s degree in Life Sciences, Pharmacy, Quality, or a related scientific discipline (a Master’s degree is considered a plus) . Proven experience in regulatory affairs, quality assurance, or compliance within the pharmaceutical or biopharmaceutical industry . Strong understanding of global health authority regulations, GxP/cGMP guidelines, ICH framework, and Health Authority structures (US, EU, Canada) . Proven capability to manage regulatory data accuracy in information management systems and lead cross-functional PTR deliverables. Advanced and fluent English language skills (both written and spoken) for daily global collaboration . No relocation benefits are offered for this position. 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.