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For Companies At a Glance
- Tasks: Lead global regulatory strategy for groundbreaking biotech therapies.
- Company: Join a pioneering biotech transforming treatments for rare pediatric conditions.
- Benefits: Impact lives directly while working in a fast-paced, innovative environment.
- Why this job: Make a real difference in children's lives with cutting-edge genetic therapies.
- Qualifications: 15+ years in regulatory affairs, advanced degree, and strong leadership experience required.
- Other info: Work with a dynamic team at a rapidly growing life sciences recruitment firm.
The predicted salary is between 72000 - 108000 £ 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 and seminars to meet potential contacts who can provide insights or referrals.
✨Tip Number 2
Stay updated on the latest regulatory changes and advancements in ASO technologies. This knowledge will not only enhance your expertise but also demonstrate your commitment to the field during networking conversations.
✨Tip Number 3
Engage with relevant online communities and forums focused on regulatory affairs and biotech. Participating in discussions can help you build your reputation and connect with others who may know about job openings.
✨Tip Number 4
Consider reaching out directly to current or former employees of the company you're interested in. They can provide valuable insights into the company culture and the specific challenges faced in the role, which can be beneficial for your application.
We think you need these skills to ace Senior Vice President / Vice President of Regulatory Affairs.
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in regulatory affairs, particularly in paediatric and rare disease programmes. Emphasise any leadership roles and specific achievements related to EU/UK submissions.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your passion for the role and the impact you wish to make in the biotech field. Mention your familiarity with ASO technologies and how your background aligns with the company's mission.
Highlight Relevant Experience: In your application, focus on your 15+ years of experience in regulatory affairs. Provide examples of successful regulatory strategies you've led, especially those involving MHRA and EMA interactions.
Showcase Leadership Skills: Demonstrate your leadership capabilities by discussing your experience in scaling regulatory operations during periods of rapid growth. Include specific instances where you advised stakeholders on regulatory risks and compliance.
How to prepare for a job interview at JR United Kingdom
✨Understand the Regulatory Landscape
Familiarise yourself with the current regulatory frameworks in the UK and EU, especially regarding paediatric and rare diseases. Being able to discuss recent changes or challenges in these areas will demonstrate your expertise and commitment to the role.
✨Showcase Leadership Experience
Prepare examples of your past leadership roles in regulatory affairs, particularly in high-growth environments. Highlight how you have successfully led teams and influenced stakeholders in previous positions, as this is crucial for a senior role.
✨Prepare for Technical Questions
Expect to be asked about specific regulatory submissions and your experience with ASO technologies. Brush up on your technical knowledge and be ready to discuss how you've navigated complex regulatory processes in the past.
✨Demonstrate Passion for Patient Impact
This role directly affects the lives of children with rare diseases. Be prepared to articulate why you are passionate about this field and how your work can contribute to improving patient outcomes. Showing genuine interest can set you apart from other candidates.
