Roche

LTO Partner Regulatory

3 days left

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
12 Apr 2021
Closes
12 May 2021
Ref
202103-106141
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

LTO Regulatory Partner 

At Roche we believe life is incredibly precious. So precious that we have recently embarked on a transformational journey so that we can deliver better outcomes to more patients faster. Our world is changing, our healthcare landscape is evolving and our portfolio is transforming - we are transforming. 

Imagine working for an organisation which focuses on putting people at the heart of what they do. Where every single person within the organisation is aligned to one main motivating force, that at the centre of everything they do, and their number one priority; are patients. A place which gives every individual the autonomy and empowerment to make a difference, where you are not defined by a job title. Imagine waking up every morning feeling fulfilled, having purpose and meaning in your work.

  Every day we strive to solve some of the greatest and most complex health challenges facing humanity.  We discover, develop and manufacture innovative solutions which detect and treat disease where there is the greatest medical need.  Our core diagnostics and biotechnology businesses work collaboratively and use data in novel ways to deliver personalised healthcare which can be tailored to meet the specific needs of individual patients.  We help millions of people all over the world live longer and better lives every hour of every day and we've been writing scientific history for over 120 years.

  None of this would be possible without our extraordinary employees; our people make our business.  Just as we believe that personalised approaches achieve the best outcomes for our patients, we offer inspirational opportunities for employees that are as unique as they are.  We have created an inclusive, respectful work environment where people can be authentic and truly invested in their work, a place to belong. Our outstanding commitment to workplace engagement has recently been recognised by our inclusion at number four on the Sunday Times Top 25 Best Big Companies to Work

Mindset and behaviour is as important to us as experience and capabilities.

We won't tell you how to behave with detailed competency frameworks; we ask you to bring your differences so we can celebrate a more diverse and inclusive workforce. 

We offer a starting point for you to consider and to reflect on what this might mean for you: we're building a culture that is centered around growth mindset, prioritisation, ownership and accountability.  We need individuals who are courageously authentic in their thinking and in their actions.  This is what excites us about our future. 

We believe that on-going personal transformation is the heart of on-going organisational transformation and that fundamental to this is knowing yourself. 

For us, knowing yourself means being aware of your own strengths and weaknesses, your passions and fears, your desires and dreams, your thoughts and feelings, your likes and dislikes, your tolerance and limitations. Knowing yourself requires you to: regularly stop, pause and reflect as you change and develop over time, invite and share feedback regularly and know where to focus your development, know when to hold things lightly and what to let go of. Knowing yourself means knowing your purpose and what fulfills you, it enables you to be authentic and truly bring your whole self to work.

 

LTO Partner: Regulatory

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.  

The activities of this group encompass:
 

 

  • Clinical Trial Applications
  • National Licensing Applications
  • Early Access to Medicines Applications 
  • National components of medicines authorisation via the European Centralised procedure.  

 


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.    

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 
  • With a broad regulatory background and experience, you will have strong Regulatory knowledge and contribute to foundation and/or squad based work as well as supporting the development of squad/chapter based plans and goals. May support the learning & development of other chapter members. An ability to understand scientific and technical information relating to an assigned portfolio of Roche products. A scientific degree is required.
  • With broad and comprehensive expertise within the Regulatory environment you will lead foundation work and partner with the business to solve complex regulatory issues that impact the chapter and/or wider business. Contributes to development of squad/chapter based strategic plans and goals. Actively contributes to the learning & development of other chapter members. An ability to understand scientific and technical information relating to an assigned portfolio of Roche products. A scientific degree is required.
  • Experienced in Medical Devices and/or CMC Regulatory Affairs.

 


If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you.  In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression. 

To be considered for this position, please apply using the link below.

When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.

 

 

 

 

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