LTO Regulatory Partner - FTC 12 months

F. Hoffmann-La Roche AG; Welwyn; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

Roche UK is seeking a Regulatory Partner on a 12-month fixed-term contract, based in Welwyn Garden City with a hybrid model (2/3 days on-site). The role focuses on shaping regulatory strategies and ensuring compliant submissions for Roche products in the UK.

You will bring regulatory expertise, collaborate across the UK Regulatory Team, and support UK CTA, SMC, and lifecycle activities while aligning with EU/regulatory guidelines.

Qualifications

• Scientific University degree required.
• Basic experience in UK Regulatory Affairs.
• Experience providing strategic and technical advice.
• Knowledge of UK and EU regulatory requirements and procedures.
• Excellent documentation skills for high-quality submissions.

Responsibilities

• Translate UK regulatory requirements into Roche policies and strategies.
• Support Clinical Trial Applications and licensing processes.
• Engage in Scientific Advice meetings and lifecycle activities.
• Collaborate with stakeholders to drive chapter/squad goals.
• Understand and communicate regulatory information for Roche products.

Skills

Scientific literacy

UK regulatory knowledge

Strategic advisory

Stakeholder management

Regulatory submissions

Education

Scientific University degree

Job description

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 LTO Regulatory Partner - 12 month Fixed Term Contract A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

The Opportunity

Location: Welwyn Garden City (Hybrid - 2/3 days per week on-site) Duration: 12-Month FTC Imagine working for an organization that puts people at the heart of everything they do, where your contributions directly impact patient outcomes. At Roche, our number one priority is our patients, and we believe that every person plays a key role in achieving this mission. As a Regulatory Partner at Roche UK, you will be a vital part of our UK Regulatory Team. You will leverage your regulatory and scientific expertise to shape and drive strategic initiatives. This is your opportunity to make a difference and be part of a company dedicated to improving lives.

UK Regulatory Team Responsibilities

The Regulatory group works with the wider business to translate the constantly evolving requirements of the UK Regulatory environment into Roche policies, procedures, solutions and strategies that ensure compliance and maximise the value for patients.

• Clinical Trial Applications
• Promising Innovative Medicine and Early Access to Medicines Applications
• Scientific Advice meetings
• Paediatric Investigation Plans
• National Licensing Applications
• International Recognition initiatives e.g. ACCESS, ORBIS
• Life Cycle Management, through to portfolio streamlining activities e.g. divestments, licence cancellations

Who You Are

You are a passionate regulatory professional with a clear vision for improving patient outcomes. You have an agile mindset with a collaborative, solution-oriented approach. With a good understanding of the pharmaceutical industry and some experience working within a regulated environment, you will leverage your regulatory knowledge and experience to deliver on foundation work and support with chapter and/or squad work. You may contribute to the development of squad/chapter-based strategic plans and goals. You will have the ability to understand scientific and technical information relating to an assigned portfolio of Roche products.

You also bring:

• A Scientific University degree
• Basic experience in UK Regulatory Affairs
• Proven experience managing UK clinical trial applications
• Experience providing strategic and technical advice
• Knowledge and experience of UK and EU regulatory requirements and procedures
• Excellent documentation skills to ensure high-quality and timely submissions
• Experience as a Subject Matter Expert (SME) in defined subject areas or therapeutic areas
• Experience managing stakeholder relationships

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.

We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future.

We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.