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- Tasks: Join Roche as a Regulatory Partner, shaping healthcare strategies and ensuring compliance.
- Company: Roche is a leading global healthcare company focused on innovation and patient care.
- Benefits: Enjoy flexible working, a gym, subsidised meals, and a vibrant office culture.
- Why this job: Make a real impact on patient outcomes while working in a diverse and inclusive environment.
- Qualifications: You need a scientific degree and extensive experience in UK regulatory affairs.
- Other info: Located in Welwyn Garden City, with easy access to London and beautiful surroundings.
The predicted salary is between 36000 - 60000 £ per year.
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
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.
As a Regulatory Partner at Roche UK, you will be a vital part of our UK Regulatory Chapter. 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 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
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.
LTO Partner: Regulatory employer: Roche
Contact Detail:
Roche Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land LTO Partner: Regulatory
✨Tip Number 1
Familiarise yourself with Roche's core values and mission. Understanding their commitment to diversity, equity, and inclusion will help you align your responses during interviews and demonstrate that you share their passion for improving patient outcomes.
✨Tip Number 2
Network with current or former Roche employees on platforms like LinkedIn. Engaging in conversations about their experiences can provide valuable insights into the company culture and expectations, which can be beneficial during your interview.
✨Tip Number 3
Stay updated on recent changes in UK regulatory affairs, especially post-Brexit. Being knowledgeable about current trends and challenges in the regulatory landscape will position you as a well-informed candidate who can contribute effectively from day one.
✨Tip Number 4
Prepare specific examples of how you've successfully navigated complex regulatory issues in the past. Highlighting your problem-solving skills and adaptability will showcase your ability to thrive in Roche's dynamic environment.
We think you need these skills to ace LTO Partner: Regulatory
Some tips for your application 🫡
Understand Roche's Values: Familiarise yourself with Roche's commitment to diversity, equity, and inclusion. Reflect this understanding in your application by highlighting how your values align with theirs.
Tailor Your CV: Ensure your CV specifically addresses the qualifications and experiences mentioned in the job description. Emphasise your expertise in UK Regulatory Affairs and any relevant experience post-Brexit.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your regulatory expertise but also demonstrates your passion for improving patient outcomes. Use specific examples of how you've contributed to similar goals in previous roles.
Highlight Collaboration Skills: Since the role requires effective cross-functional collaboration, make sure to include examples of past experiences where you successfully worked with diverse teams or stakeholders to achieve regulatory compliance.
How to prepare for a job interview at Roche
✨Understand Roche's Values
Before your interview, take some time to research Roche's commitment to diversity, equity, and inclusion. Be prepared to discuss how these values resonate with you and how you can contribute to creating a more inclusive environment.
✨Showcase Your Regulatory Expertise
Highlight your extensive experience in UK Regulatory Affairs, especially post-Brexit submissions. Be ready to provide specific examples of how you've navigated complex regulatory issues and contributed to strategic initiatives in previous roles.
✨Demonstrate Cross-Functional Collaboration
Roche values effective collaboration across teams. Prepare to discuss instances where you've successfully worked with different departments or stakeholders to achieve regulatory compliance or improve patient outcomes.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and adaptability. Think about past challenges you've faced in regulatory affairs and how you approached them, focusing on your strategic thinking and negotiation skills.
