Regulatory Transparency (Disclosures) Professional in Welwyn Garden City

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.

As a member of the PD Regulatory Data and Content Chapter, you will join a flexible and bold team dedicated to end-to-end data interpretation and submission excellence. You will play a vital role in developing our portfolio by ensuring high-quality clinical project data reaches global Health Authorities and the public domain. This is an opportunity to lead impactful work within a culture that values continuous learning, innovation, and a strong sense of purpose for our patients.

In this role, you will be responsible for the end-to-end execution of clinical trial registration and results posting, ensuring Roche remains compliant with global regulations, including those from the FDA, EMA, and Health Canada. You will manage the balance between clinical transparency and the protection of company confidential information and personal data.

• Lead the accurate and timely posting of applicable Genentech and Roche clinical trial protocols and study results to public trial registration websites, including ClinicalTrials.gov and the EU results registry.
• Identify studies requiring registry and results postings, including applicable trials for disclosure on relevant external websites, and ensure responsible PDR management and staff are aware of timelines, deadlines, and requirements.
• Liaise with project teams and affiliates to ensure clarity around roles and responsibilities related to regulatory disclosures.
• Submit protocol documents for registry entry preparation and quality control checks, ensuring consistency between protocols and registry entries, as well as cross-protocol and franchise alignment.
• Collaborate with cross-functional stakeholders to obtain the data, reviews, and approvals needed to complete registry and results entries on internal and external systems.
• Monitor workflows for registry and results entries to ensure timely and accurate completion.
• Complete document and data uploads in applicable systems.
• Track correspondence with cross-functional teams and departments, ensuring timely and appropriate responses.

You are a detail-oriented professional with a passion for data transparency and a strong sense of urgency. You thrive in matrix-based environments and possess the project management skills required to independently lead complex, molecule-enabling projects. You also have:

• A degree in Life Sciences or equivalent.
• Previous experience in regulatory affairs or other product development functions is preferred.
• Solid understanding of the drug development process, including regulations and processes related to clinical trial disclosure.
• Hands-on experience with clinical trial registry and results postings.
• Demonstrated leadership experience in managing complex projects within cross-functional, matrix-based team environments.
• Strong computer skills, including proficiency in Microsoft Office (Word, PowerPoint, and Excel) and Adobe Acrobat.
• Understanding of international regulations, processes, and issues in drug and biologics development is preferred, including GxP and GCP.
• Excellent interpersonal and communication skills in a global environment, with the ability to collaborate effectively across functions and operate with a strong sense of urgency.
• Proven ability to independently lead and deliver complex projects, supported by strong administrative and project planning skills, high attention to detail, and the ability to deliver high-quality work under tight timelines.
• Fluency in English, both written and spoken.

This role is based onsite at our Welwyn, United Kingdom office. Our team follows a hybrid work structure. 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.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants' requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.