At a Glance
- Tasks: Shape strategic initiatives in regulatory affairs to improve patient outcomes.
- Company: Join Roche UK, a leader in healthcare innovation.
- Benefits: Flexible working, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on mentorship and career development.
- Why this job: Make a real difference in patients' lives while navigating the evolving regulatory landscape.
- Qualifications: Passion for regulatory affairs and a scientific degree 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
- 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.
Qualifications
- 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
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 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 commitment to flexible working arrangements. Join us in a role where your expertise will be valued, and your contributions will directly impact the lives of patients across the UK.
StudySmarter Expert Advice🤫
We think this is how you could land LTO Regulatory Partner in Welwyn
✨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 maybe even a referral, which can really boost your chances.
✨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. Show them you’re not just a fit for the role, but for the company culture too!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After your interview, send a thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds and shows your professionalism.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in being part of the Roche team.
We think you need these skills to ace LTO Regulatory Partner in Welwyn
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that match the job description. Highlight your regulatory expertise and any relevant projects you've worked on, especially those related to UK submissions post-Brexit.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're passionate about improving patient outcomes. Share specific examples of how you've navigated complex regulatory issues and contributed to strategic initiatives in your previous roles.
Showcase Your Documentation Skills:Since excellent documentation is key for this role, consider including a brief example of a successful submission or project where your documentation made a significant impact. This will demonstrate your attention to detail and ability to deliver high-quality work.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows your enthusiasm for joining our team at Roche UK!
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. Be ready to discuss how your experience aligns with Roche's needs, especially post-Brexit submissions. This shows you're not just knowledgeable but also genuinely interested in the role.
✨Showcase Your Strategic Thinking
Prepare examples of how you've developed and implemented regulatory strategies in the past. Think about specific challenges you've faced and how you navigated them. This will demonstrate your ability to think critically and adaptively, which is key for a Regulatory Partner.
✨Highlight Your Collaboration Skills
Since the role involves cross-functional collaboration, be ready to share instances where you've successfully worked with different teams. Emphasise your negotiation skills and how you've influenced outcomes positively, as this will resonate well with Roche's collaborative culture.
✨Be Ready to Mentor
Roche values learning and development, so think about how you've mentored others in your previous roles. Share specific examples that highlight your ability to guide peers and contribute to team growth, showing that you're not just a regulatory expert but also a team player.
