
LTO Graduate Partner (12 months) Welwyn, England
Job description
About Roche UK
Roche is a leading investor in UK Healthcare. We invest in our future through research and development, and in our people through continuing professional development.
We’re here to deliver better outcomes to more patients, faster. That means the world to us.
Our achievements help to transform the lives of millions of people. We’ve been supporting patients for over 100 years in the UK, building a reputation that we’re intensely proud of. Through this success, we’ve set an incredibly high standard. Those expectations continue to grow. The environment in which we operate changes at an ever-increasing pace. The industry is never going to stand still.
As one united team at Roche UK, we know we need to boldly respond to these changes whilst keeping our customers and our patients at the heart of everything we do.
So, we’re shooting for the stars, transforming ourselves into a much more open, dynamic, transparent, inclusive, collaborative and agile business.
Regulatory: Expectations
The Regulatory team 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.
The team are Roche’s primary contact with the MHRA, requiring the ability to work effectively cross functionally at a local and global level as well as the capability to negotiate and influence externally.
The Regulatory partners need to be adaptable to change and entrepreneurial in nature in order to identify opportunities, while maintaining a laser focus on ensuring compliance and therefore playing a key role in retaining Roche UK’s Licence to Operate.
The activities of this group encompass:
Clinical Trial Applications (CTAs)
National Licensing Applications
Early Access to Medicines Applications
National components of medicines authorisation via the European Centralised procedure.
As a LTO Graduate Regulatory Partner, you are responsible for:
The regulatory management and all related associated activities including systems with UK CTAs for assigned products.
Maintaining high ethical standards and complying with all applicable laws, regulations, industry codes and internal policies and procedures.
Being a subject matter expert (SME) for the department in clinical trial related subject or process areas.
Individuals should be operating in one or more of the following categories:
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 required foundation work and support with chapter and/or squad work
An ability to understand scientific and technical information relating to an assigned portfolio of Roche products.
A scientific degree is required.
Application process:
Phase I:
Purpose - our focus on this first stage is to understand why you have applied for this role and what you will bring to the role to ensure team and personal success.
Cover letter & CV
As part of your cover letter, Roche is keen to understand your motivation in applying for this position. You should, therefore, provide responses to the following:
Why Roche: What do you know about Roche and why do you want to work here?
Why you: If you had to choose a single example or achievement in your life, that you feel would make you suitable for this role, what would it be and why?
Your cover letter should not exceed one page.
** note any application without a cover letter will be automatically rejected. **
Phase II:
Face to face interview in August 2023
Start Date: September 2023 (tbc)
Application Deadline: 8th August 2023
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.
Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. 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.
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.
