LTO Regulatory Partner

Roche; Welwyn; On-site; GBP 70,000 - 95,000; Full time

Job summary

Roche UK seeks a regulatory expert to navigate the evolving UK regulatory landscape and ensure submissions meet high-quality standards. The role focuses on translating regulatory requirements into Roche policies, enabling patient access and protecting Roche's license to operate.

You will engage with internal teams and external authorities to drive regulatory strategies across medicines and diagnostics, contributing to a patient-centered healthcare future.

Qualifications

• Broad and comprehensive expertise within the UK regulatory environment.
• Experience managing UK submissions post-Brexit and maintaining compliance.
• Proven ability to develop, implement and communicate regulatory strategies.

Responsibilities

• Translate evolving UK regulatory requirements into Roche policies, procedures and strategies.
• Collaborate with cross-functional teams to ensure regulatory compliance and maximize patient value.
• Lead foundational regulatory work and partner with the business to solve complex issues.

Skills

UK Regulatory Affairs

Post-Brexit submissions

Regulatory strategy

Documentation

Stakeholder management

Mentoring peers

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

About Roche UK

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

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.

UK Regulatory Group Responsibilities

The Regulatory group collaborates 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 maximize the value for patients.

Our activities encompass:

• Clinical Trial Applications
• National Licensing Applications
• Early Access to Medicines Applications
• National components of medicines authorization via the European Centralized procedure

The team serves as Roche's primary contact with the MHRA, requiring effective cross-functional collaboration at both local and global levels, as well as the capability to negotiate and influence externally. Regulatory Partners need to be adaptable and entrepreneurial to identify opportunities, while maintaining a focused approach on ensuring compliance and playing a key role in retaining Roche UK's License to Operate.

Who You Are

You are a passionate regulatory expert with a clear vision for improving patient outcomes. With broad and comprehensive expertise within the UK regulatory environment, you will lead foundational work and partner with the business to solve complex regulatory issues impacting the chapter and/or wider business. You will contribute to the development of squad/chapter-based strategic plans and goals, and actively participate in the learning and development of other chapter members. 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
• Extensive experience in UK Regulatory Affairs
• Proven experience managing UK submissions post-Brexit
• Experience providing strategic and technical advice
• In-depth knowledge and experience of UK and EU regulatory requirements and procedures
• A proven track record of developing, implementing, and communicating regulatory strategies
• 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 in mentoring peers, as well as 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.