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- Tasks: Lead global regulatory strategy for groundbreaking genetic therapies in paediatric care.
- Company: Join a pioneering biotech transforming treatments for rare neurodegenerative conditions in children.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and impactful contributions.
- Why this job: Make a real difference in patients' lives while working in a fast-paced, innovative industry.
- Qualifications: 15+ years in regulatory affairs, advanced degree, and experience in paediatric and rare disease programmes required.
- Other info: This role offers the chance to shape regulatory operations during rapid organisational growth.
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 in paediatric and rare disease programmes. Attend industry conferences or webinars to connect with key players and learn about the latest trends and challenges in the sector.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks of the UK and EU, particularly regarding ASO therapies. 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 communities and forums related to regulatory affairs in biotech. Sharing insights and asking questions can help you build a reputation as a knowledgeable professional in the field, which may catch the attention of recruiters.
✨Tip Number 4
Consider reaching out to current or former employees of the company you're applying to. They can provide valuable insights into the company culture and expectations, which can help you tailor your approach and stand out during the interview process.
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 liaising with authorities like MHRA and EMA.
Showcase Leadership Skills: Demonstrate your leadership capabilities by discussing your experience in scaling regulatory operations during periods of rapid growth. Include any relevant metrics or outcomes that showcase your effectiveness in previous roles.
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 how you've successfully led teams or projects in regulatory affairs. Highlight your experience in engaging with regulatory agencies like the MHRA and EMA, as this will be crucial for the position.
✨Emphasise Your Technical Knowledge
Be ready to discuss your understanding of ASO technologies and their application in genetic therapies. This technical knowledge is vital for the role and will set you apart from other candidates.
✨Demonstrate Adaptability
Given the fast-paced nature of the biotech industry, share instances where you've successfully navigated rapid organisational growth or change. This will show that you can thrive in a dynamic environment, which is essential for this position.
