Specialist

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 Opportunity

At Roche, everything we do is rooted in our purpose: creating a healthier future for generations to come. We are driven by science, inspired by patients, and committed to making more time for the moments that matter.

We're looking for a Regulatory Affairs Professional to join our Product Development Regulatory (PDR) team, specialising in labelling. In this pivotal role, you'll contribute to the development and lifecycle management of medicinal products by crafting high-quality regulatory labelling strategies and documentation that serve both patients and healthcare professionals around the world.

• Contribute to the global product team in crafting and maintaining the company Core Data Sheet (CDS), core Patient Product Information (cPPI), and key local product labels for the EU and US throughout the lifecycle of pharmaceutical products and devices, ensuring compliance with labelling requirements.

• Apply critical thinking and effective data messaging in the creation and maintenance of regulatory labelling documents, ensuring clarity and accuracy in product information.

• Lead or contribute to company documents and responses to Health Authority requests related to product labelling, facilitating clear communication and compliance with regulatory standards.

• Guide the product team and country affiliates in the implementation of CDS updates to local labels, ensuring consistency and adherence to global regulatory requirements

• Support the development of SOPs and systems for regulatory labelling to ensure end-to-end compliance throughout the product lifecycle

• Stay up to date with evolving global regulations, competitive landscapes, and internal policies to inform strategic labelling decisions
  

Who You Are

• You hold a Bachelor's degree and bring experience in regulatory affairs, preferably with a focus on labelling

• You're well-versed in Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP)

• You think critically, communicate clearly, and balance regulatory compliance with scientific and patient-centric thinking

• You thrive in a collaborative environment, building trust and sharing insights across global teams

• You're curious, adaptable, and eager to continuously learn in a fast-paced, purpose-driven organisation
  

Ready to shape the future of global product labelling? Apply now and join us as our next Regulatory Program Management Specialist - Labelling.

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.