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

The Opportunity We are looking for individuals with diverse experiences to enhance our capabilities at Roche and make a meaningful impact for patients. This role supports both Roche Pharma and Diagnostics by managing trial registration, results posting in line with US and EMA regulations, and ensuring document transparency through the redaction and public release of clinical study documents (e.g., CSRs, protocols) as required by EMA, Health Canada, and FDA regulations, as well as the Roche Data Sharing Policy. Partnering with internal stakeholders, this role ensures compliance with regulatory requirements while safeguarding Personal Protected Data (PPD) and Company Confidential Information (CCI). The Disclosure Specialist will also engage with Health Authorities and Affiliates to set appropriate disclosure levels and actively participate in industry groups to stay informed and influence emerging regulatory developments.

• Lead accurate and timely posting of Genentech and Roche clinical trial protocols and study results on public trial registration websites such as ClinicalTrials.gov and the EU results registry
• Identify studies requiring registry and results postings, ensuring responsible PDR management and staff are informed of timelines, deadlines, and requirements
• Liaise with project teams and affiliates to ensure they understand their regulatory disclosure responsibilities
• Submit protocol documents for registry entry preparation and quality control checks to ensure consistency within the registry, protocol, and across franchises
• Collaborate with cross-functional team members to acquire data, reviews, and approvals needed to complete registry and results entries on internal and external websites
• Monitor workflows for registry and results entries to ensure they are completed on time and meet objectives
• Manage document and data uploads in applicable systems, while tracking correspondence with cross-functional teams to ensure timely responses

Who You Are

• Possess a degree in Life Sciences (or equivalent) with at least 5 years of relevant experience, and a proven ability to independently lead complex molecule and molecule-enabling projects
• Demonstrated experience in leading cross-functional teams, generating insights, and working effectively in a matrix-based, global environment with strong interpersonal and communication skills
• Solid understanding of the drug development process, relevant regulations (e.g., clinical trial disclosure, GxP, GCP), and working knowledge of multidisciplinary functions such as clinical development, clinical operations, and biostatistics
• Proficiency in computer skills, including Microsoft Office Suite (Word, PowerPoint, Excel) and Adobe Acrobat, with fluency in English (both verbal and written)
• Previous experience in regulatory affairs or other product development functions is preferred, along with the ability and willingness to travel as needed

Relocation benefits are not available 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.