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.
Let’s build a healthier future, together.
By combining our unique strengths, we’re redefining healthcare through sustainable action and innovation. Discover what it’s like to work at Roche.
The Opportunity
PTR regulatory professionals deepen their regulatory expertise and apply it to deliver on our North Star. We encourage bold innovation and collaboration to create meaningful outcomes for patients, stakeholders, and the company. Your role may include: partnering with key stakeholders, managing molecule portfolios, collaborating with affiliates, influencing health authorities, and driving strategic initiatives. All PTR members share responsibility for maintaining our License to Operate through GxP compliance and adherence to the Roche Group Code of Conduct—including ensuring you have the appropriate training, experience, and qualifications for your work.
Responsibilities
Manage regulatory information: Track, monitor, and ensure compliance of regulatory data for submissions and internal/external requirements globally.
Execute submission processes: Perform submission steps in the regulatory information management system according to defined roles and responsibilities.
Coordinate document management: Edit, format, and manage technical documents (e.g., eCTD) for regulatory compliance; control versioning throughout the submission lifecycle.
Plan and track submissions: Partner with PTR Squad Members to coordinate submission generation, manage timelines, and ensure timely stakeholder communication.
Develop regulatory data strategy: Collaborate across PT, PD, pRED, and gRED to align data monitoring, evaluation, and system workflows; manage master data and governance standards globally.
Support process improvement: May act as Business Process Owner/Subject Matter Expert; provide input on system enhancements, vendor partnerships, and process documentation/training.
Who you are
We are seeking an individual with 1-2+ years of related experience in a similar role. BA or BS (or equivalent) degree in English, biology, chemistry, pharmacy, or a related field or a degree as laboratory assistant (e.g., CTA, BTA, or PTA) is preferred.
Good understanding of our regulatory strategy and processes, thinking creatively, has an ability to understand and adapt to change, and proactively seeks opportunities to learn and practice new skills. Applies expertise to contribute to a broader range of deliverables.
Oversee and be the main point of resource for junior colleagues, may deal with sensitive cases and support the team and processes as a mentor.
Support project activities.
Influence not only our own team and processes, but also the outcomes of projects or customer activities. Influence (internal and/or external) on deliverables.
Preferred
Experience with Veeva RIM (Regulatory Information Management) system.
Relocation benefits are not available for this job posting.
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.