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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 role with potential for remote work and competitive perks.
- Why this job: Make a real difference in patients' lives while working in a dynamic, fast-paced environment.
- Qualifications: 15+ years in regulatory affairs, advanced degree, and experience in paediatric and rare diseases required.
- Other info: Opportunity to scale operations during rapid growth in a leading 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 colleagues and learn about the latest trends in regulatory strategies.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements of the UK and EU, particularly regarding ASO technologies. Understanding the nuances of these regulations will not only enhance your knowledge but also demonstrate your commitment to the role during discussions.
✨Tip Number 3
Engage with online forums and social media groups focused on regulatory affairs in biotech. This can help you stay updated on industry news and connect with others who may provide insights or referrals for the position.
✨Tip Number 4
Consider reaching out to current or former employees of the company to gain insights into their culture and expectations. This information can be invaluable in tailoring your approach and demonstrating your fit for the role.
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 advancing genetic therapies and your understanding of the regulatory landscape. Mention your experience liaising with regulatory authorities like MHRA and EMA.
Highlight Relevant Experience: In your application, focus on your 15+ years of experience in the pharma/biotech sector. Provide examples of how you've successfully scaled regulatory operations in high-growth environments.
Showcase Your Educational Background: Include details about your advanced degree (PhD, PharmD, or MSc) in a scientific discipline. This will reinforce your qualifications for the role and demonstrate your expertise in the field.
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 relevant to paediatric and rare disease programmes. 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, especially in high-growth environments. Highlight specific examples where you successfully led teams or projects, focusing on your strategic decision-making and problem-solving skills.
✨Engage with Current Trends
Stay updated on the latest trends and advancements in biotech, particularly in genetic therapies and rare diseases. Being able to reference recent developments during your interview will show your passion for the field and your commitment to staying informed.
✨Prepare for Scenario-Based Questions
Anticipate scenario-based questions that may assess your ability to handle regulatory challenges. Think through potential situations you might face in this role and prepare structured responses that highlight your analytical thinking and regulatory knowledge.
