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- Tasks: Lead global regulatory strategy for groundbreaking biotech therapies.
- Company: Join a pioneering biotech transforming treatments for rare pediatric conditions.
- Benefits: Impactful work with potential for remote flexibility and competitive perks.
- Why this job: Make a real difference in patients' lives while shaping the future of healthcare.
- Qualifications: 15+ years in regulatory affairs, advanced degree, and strong leadership experience required.
- Other info: Opportunity to work in a fast-paced, high-growth environment.
The predicted salary is between 43200 - 72000 £ per year.
A pioneering biotech focused on individualized therapies for rare pediatric neurodegenerative conditions is seeking a Senior Vice President / Vice President of Regulatory Affairs. This executive role will lead global regulatory strategy, with a particular focus on the UK and EU, supporting the development of advanced genetic therapies using ASO technologies. This company is transforming the treatment landscape for children with devastating, life-limiting neurological diseases—offering an opportunity to directly impact the lives of patients and families with few, if any, existing therapeutic options.
Key Responsibilities
- Lead regulatory strategy and submissions across the UK, EU, and potentially the US
- Liaise with MHRA, EMA, and other authorities to ensure regulatory alignment
- Advise internal stakeholders on regulatory risks and compliance
- Represent the company in external regulatory forums and industry groups
- Scale regulatory operations during rapid organizational growth
Requirements
- 15+ years’ experience in regulatory affairs within pharma/biotech, with significant experience in paediatric and rare disease programmes
- Proven leadership in EU/UK submissions and regulatory agency engagement
- Strong background in rare diseases, ASO therapies, or pediatric disorders
- Advanced degree (PhD, PharmD, or MSc) in a scientific discipline
- Experience operating in high-growth environments with global scope
Senior Vice President / Vice President of Regulatory Affairs. employer: JR United Kingdom
Contact Detail:
JR United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Vice President / Vice President of Regulatory Affairs.
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with paediatric and rare disease programmes. Attend industry conferences or webinars to connect with key players and gain insights into the latest trends and challenges in regulatory strategy.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements of the MHRA and EMA, as well as any recent changes in legislation that may impact your role. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 3
Showcase your leadership skills by discussing past experiences where you successfully led teams through complex regulatory submissions. Highlight any instances where you navigated challenges in high-growth environments, as this is crucial for the role.
✨Tip Number 4
Engage with online communities and forums related to regulatory affairs and biotech. Sharing your insights and learning from others can enhance your visibility and establish you as a knowledgeable candidate in the field.
We think you need these skills to ace Senior Vice President / Vice President of Regulatory Affairs.
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Vice President / Vice President of Regulatory Affairs position. Tailor your application to highlight your relevant experience in regulatory affairs, particularly in paediatric and rare disease programmes.
Craft a Compelling CV: Your CV should clearly outline your 15+ years of experience in regulatory affairs, focusing on your leadership roles and specific achievements in EU/UK submissions. Use quantifiable metrics where possible to demonstrate your impact in previous positions.
Write a Strong Cover Letter: In your cover letter, express your passion for transforming the treatment landscape for children with neurological diseases. Highlight your experience with ASO therapies and your ability to liaise with regulatory authorities like MHRA and EMA.
Review and Submit: Before submitting your application, review all documents for clarity and accuracy. Ensure that your application reflects your qualifications and enthusiasm for the role. Submit your application through our website to ensure it reaches the hiring team directly.
How to prepare for a job interview at JR United Kingdom
✨Understand Regulatory Frameworks
Familiarise yourself with the regulatory frameworks in the UK and EU, particularly those related to paediatric and rare diseases. Being able to discuss specific regulations and how they impact the development of ASO therapies will demonstrate your expertise.
✨Showcase Leadership Experience
Prepare to discuss your previous leadership roles in regulatory affairs. Highlight specific examples where you successfully led teams or projects, especially in high-growth environments, as this is crucial for the role.
✨Engage with Current Trends
Stay updated on the latest trends and advancements in biotech, particularly in genetic therapies and regulatory changes. This knowledge will help you engage in meaningful discussions during the interview and show your passion for the field.
✨Prepare Questions for the Interviewers
Think of insightful questions to ask the interviewers about the company's vision, challenges in regulatory affairs, and their approach to scaling operations. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
