Regulatory Partner

7 months ago

Welwyn, United Kingdom Roche Full time

The Position

Regulatory Partner (Medical Devices) 

About Roche UK:

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 125 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.

Our Commitments:

“Better outcomes to more patients, faster.”

● Healthcare partners are ‘wowed’ when they work with us

● Our innovations are faster and bolder 

● We provide services and products to better serve people

● Purpose is our primary motivator

● We spend our time contributing where it adds the most value

… we ensure brilliance across the organisation

… we can feel brave, innovate and take calculated risks within legal and ethical fearing consequences if things “go wrong”

… we can bring our authentic selves to work 

… we do not need permission. We take personal accountability and trust each other..

… we can develop our career based on our passion, experience & behaviour and play to our strengths … we work within less hierarchy – and with more coaching 

… everyone can be a leader, regardless of role

… we aim to spend 20% of our time on personal development

Our UK operating model is based on the following principles:

●  Flexible resourcing across fit-for-purpose teams to address specific needs and priorities

● Healthcare-driven focus through outcomes

● Consultation, individual empowerment & accelerated decision-making through decentralisation

● Customer focus through mutually beneficial partnerships

● Collaboration

● Transparent portfolio level prioritisation

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.

Regulatory Partner Expectations: 

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 maximum value to patients. As a Regulatory Partner with a medical devices background, you will be focussed on supporting the delivery of our broad and innovative first in class combined drug/device portfolio. As our integrated solutions ecosystem transforms, you will play a critical role in contributing to our strategic objectives in building this capability within the UK Pharma regulatory team and work towards establishing strong internal and external networks to shape the regulatory environment.

The activities of this Partner encompass: 

Provide regulatory expertise on new product development and submission planning to project teams Squads, Work Packages, etc) to ensure optimal time to approval and continued regulatory compliance in maintenance of the lifecycle.  Drive and support MHRA interactions that concerns combination and/or medical device product submission strategy

Ensure that regulatory requirements are met for Clinical Trial Applications that involve Medical Devices of any nature physical devices, digital devices, in-vitro diagnostics, etc)

Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information

Provide support for the implementation/adaptation of the medical device structure across the UK Affiliate

Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance

Advice the manufacturers/global team to obtain and maintain a UKCA mark and/or any relevant regulatory milestone that concern the UK

Continuously monitor the changes to the UK Regulatory environment and provide an impact assessment on changes to the current framework and/or implementation of new RegulationsBe part of Trade Associations ABPI, MedTech, etc) working groups and gather regulatory intelligenceKeep track of changes and/or implementation of regulations relevant to medical devices, such as (but not limited to) Sustainability/Environment, etc

Provide training/mentorship and/or coaching support as required on medical device regulation and all its related aspects

Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines

Assess changes to existing products and company practices and provide an impact assessment, where necessary

Review Marketing materials and provide advice to the commercial teams on business-related activities

Who you are: 

With a good understanding of the medical devices industry (desirable pharmaceutical/biotech industry) and experience working within a regulated environment, you are in pursuit of seeking greater depth and exposure to medical devices and combination regulatory strategies within the pharma sector

An ability to understand scientific and technical information relating to an assigned portfolio of Roche products. 

With a strong track record of working in matrix teams and a passion for problem solving, you will contribute and/or lead to deliver innovative solutions to complex and/or ambiguous regulatory issues that impact the chapter and/or wider business. 

You will have experience in developing or contributing to product level plans and goals.

You will hold a scientific degree 

Please apply with a copy of your CV and a cover letter. Good luck with your application

This role unfortunately does not offer relocation or sponsorship support.

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