At a Glance
- Tasks: Lead global regulatory strategy for groundbreaking therapies in paediatric neurodegenerative conditions.
- Company: Join a pioneering biotech transforming treatments for rare diseases in children.
- Benefits: Impactful work with potential for rapid career growth and collaboration with industry leaders.
- Why this job: Make a real difference in patients' lives while working in a dynamic, innovative environment.
- Qualifications: 15+ years in regulatory affairs, advanced degree, and experience in paediatric or rare disease programmes required.
- Other info: EU work permit required; opportunity to shape the future of healthcare.
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 and seminars to meet potential colleagues and mentors who can provide insights into the role and company.
✨Tip Number 2
Familiarise yourself with the latest regulations and guidelines from the MHRA and EMA, as well as any recent changes that may impact the biotech sector. This knowledge will not only prepare you for interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 3
Showcase your leadership skills by discussing past experiences where you successfully led teams or projects in high-growth environments. Prepare specific examples that highlight your ability to navigate complex regulatory landscapes and drive strategic initiatives.
✨Tip Number 4
Engage with online communities and forums related to regulatory affairs and biotech. Participating in discussions can help you gain visibility and connect with others in the industry, potentially leading to referrals or insider information about job openings.
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 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 their regulatory strategies and challenges. This not only shows your interest in the company but also your proactive approach to understanding their needs.