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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: Impact lives directly, work in a fast-paced environment, and collaborate with top industry experts.
- 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 experience in paediatric and rare disease programmes.
- Other info: Contact Patricia at Life Sciences Recruitment for more details on this exciting opportunity.
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
Contact Detail:
Life Sciences Recruitment 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 biotech and regulatory affairs sectors. Attend industry conferences, webinars, and networking events to connect with key players and learn about the latest trends in regulatory strategies for paediatric therapies.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks of the UK and EU, particularly regarding ASO technologies and rare diseases. Understanding the nuances of these regulations will help you demonstrate your expertise during interviews.
✨Tip Number 3
Engage with relevant professional associations or groups focused on regulatory affairs and paediatric medicine. This can provide you with valuable insights and connections that may lead to job opportunities within the sector.
✨Tip Number 4
Showcase your leadership experience in high-growth environments by discussing specific examples where you've successfully navigated regulatory challenges. This will highlight your capability to scale operations effectively, which is crucial for this role.
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, especially in paediatric and rare disease programmes.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 15+ years of experience in regulatory affairs within pharma/biotech. Be specific about your leadership roles in EU/UK submissions and your engagement with regulatory agencies like MHRA and EMA.
Showcase Your Impact: Demonstrate how your previous work has positively impacted patients or contributed to the development of therapies. Use quantifiable achievements where possible to illustrate your success in high-growth environments.
Craft a Compelling Cover Letter: Write a tailored cover letter that not only outlines your qualifications but also expresses your passion for transforming the treatment landscape for children with neurological diseases. Make it clear why you are the right fit for this pioneering biotech company.
How to prepare for a job interview at Life Sciences Recruitment
✨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 and preparedness.
✨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, particularly those involving complex submissions to regulatory agencies.
✨Engage with Real-World Scenarios
Be ready to tackle hypothetical scenarios that may arise in regulatory strategy. This could include how you would handle a regulatory setback or how to align internal stakeholders on compliance issues. Your ability to think critically and strategically will be key.
✨Express Passion for Patient Impact
Convey your genuine interest in making a difference in the lives of patients, especially children with rare neurodegenerative conditions. Sharing personal motivations or experiences related to this field can resonate well with interviewers and show your commitment to the role.
