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Roche

Regulatory Disclosures Specialist

Posted Yesterday
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In-Office
Welwyn, Welwyn Hatfield, Hertfordshire, England
Mid level
In-Office
Welwyn, Welwyn Hatfield, Hertfordshire, England
Mid level
The Regulatory Disclosures Specialist supports global compliance by managing the public disclosure of clinical trial information, ensuring accurate posting, coordinating workflows, and driving project management efforts in regulatory affairs.
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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

In Product Development Regulatory Affairs (PDR), we are a flexible, bold, and distinctive regulatory organization that innovates quickly to make a meaningful impact for patients. You will join the PD Regulatory Data and Content Chapter, a community that drives the end-to-end strategy, generation, and execution of content and data to support the entire Roche portfolio, ensuring we deliver high-quality, impactful submissions to global Health Authorities.

The Opportunity

As a Regulatory Disclosure Specialist, you will play a critical role in supporting global compliance and transparency by assisting with the public disclosure of Roche's clinical trial information. This rewarding role offers a chance to apply your attention to detail and organizational skills to help accelerate medical advances for society.

  • Assist in the accurate and timely posting of applicable clinical trial protocols and study results to public websites and the EU results registry.

  • Support the coordination of disclosure workflows, helping to identify required studies and timelines, and tracking progress from initiation to completion.

  • Collaborate with project teams, affiliates, and cross-functional partners to ensure alignment on regulatory disclosure requirements.

  • Contribute to the submission and quality control of protocol documents, ensuring consistency between registry entries and the final protocol.

  • Help drive functional excellence within Regulatory Disclosures by applying process and project management skills, supporting a culture of trust and collaboration.
     

Who you are

You are a detail-oriented team player who thrives in a global, matrix-based environment. You have a strong sense of responsibility, high ethical standards, and the ability to deliver quality work under tight timelines.

  • Degree in Life Sciences or equivalent.

  • Relevant experience in the pharmaceutical or biotechnology industry, demonstrating the ability to independently manage assigned activities and support broader project goals.

  • Working knowledge of multidisciplinary functions involved in product development (e.g., clinical development, biostatistics) and a good understanding of the drug development process.

  • Fluency in English, both verbal and written, with strong interpersonal and communication skills.

  • Experience in regulatory affairs or related product development functions, and an understanding of clinical trial disclosure and international regulations (including GxP and GCP), is preferred.

 

 

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.

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.

Top Skills

GCP
Gxp

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