At a Glance
- Tasks: Shape strategic initiatives and ensure compliance in the UK regulatory environment.
- Company: Join Roche UK, a leader in improving patient outcomes.
- Benefits: Flexible working, competitive salary, and opportunities for professional growth.
- Other info: Collaborative team environment with a focus on mentorship and career development.
- Why this job: Make a real difference in healthcare while developing your regulatory expertise.
- Qualifications: Scientific degree and extensive experience in UK Regulatory Affairs required.
The predicted salary is between 60000 - 80000 £ per year.
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.
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.
Qualifications
- 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
EEO Statement
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.
LTO Regulatory Partner in Welwyn Garden City employer: F. Hoffmann-La Roche AG
At Roche UK, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. As a Regulatory Partner, you will not only have the opportunity to influence strategic initiatives that improve patient outcomes but also benefit from extensive professional development opportunities and a supportive environment that values flexibility and work-life balance. Join us in our mission to make a meaningful impact in healthcare while advancing your career in a dynamic and inclusive setting.
StudySmarter Expert Advice🤫
We think this is how you could land LTO Regulatory Partner in Welwyn Garden City
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Roche UK on LinkedIn. A friendly chat can give you insider info and might just get your foot in the door.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of UK regulatory affairs. Be ready to discuss how your experience aligns with Roche's mission to improve patient outcomes.
✨Tip Number 3
Show off your adaptability! During interviews, share examples of how you've navigated complex regulatory challenges. This will highlight your entrepreneurial spirit and problem-solving skills.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the Roche team.
We think you need these skills to ace LTO Regulatory Partner in Welwyn Garden City
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your regulatory expertise and experience in the UK regulatory environment. We want to see how your skills align with the role of Regulatory Partner at Roche UK!
Showcase Your Achievements:Don’t just list your responsibilities; share specific examples of how you've successfully navigated UK submissions or influenced regulatory strategies. We love seeing concrete results that demonstrate your impact!
Be Clear and Concise:When writing your application, keep it straightforward and to the point. We appreciate clarity, so make sure your key points stand out and are easy to read. Remember, less is often more!
Apply Through Our Website:We encourage you to submit your application directly through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at F. Hoffmann-La Roche AG
✨Know Your Regulatory Stuff
Make sure you brush up on the latest UK regulatory requirements and procedures. Being able to discuss recent changes, especially post-Brexit, will show that you're not just knowledgeable but also proactive in staying updated.
✨Showcase Your Strategic Thinking
Prepare examples of how you've developed and implemented regulatory strategies in the past. Be ready to discuss how you can leverage your expertise to drive strategic initiatives at Roche and improve patient outcomes.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working with various teams, think of instances where you've successfully collaborated across functions. Highlight your ability to negotiate and influence stakeholders, as this will be key in your role as a Regulatory Partner.
✨Be Ready to Mentor
As a potential mentor for other chapter members, come prepared to discuss your mentoring experiences. Share how you've helped peers grow and how you plan to contribute to the learning and development culture at Roche.
