Roche
LTO Regulatory Partner - FTC 12 months
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At Roche
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.
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The activities of this group encompass but not limited to:
- 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
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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.
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