At a Glance
- Tasks: Lead regulatory efforts for a cutting-edge stem cell therapy launch.
- Company: Innovative therapeutics company in the heart of London.
- Benefits: Competitive day rate, hybrid work model, and potential for long-term engagement.
- Why this job: Make a real impact in advanced therapies and shape the future of healthcare.
- Qualifications: Experience with ATMPs and direct engagement with MHRA required.
- Other info: Fast-paced environment with opportunities for professional growth.
The predicted salary is between 60000 - 80000 £ per year.
Location: London (hybrid)
Engagement: Full‑time consulting for 3 months initially, then a long-term arrangement
Sector: Cell Therapy | Stem Cells | GMP | Advanced Therapies
Regulatory Bodies: MHRA | CQC
We are supporting a therapeutics company that is preparing to launch an advanced stem cell therapy platform. They are now seeking an experienced Regulatory Consultant to step in immediately and take ownership of regulatory remediation and stakeholder engagement. This is a highly visible, high‑pressure engagement with strong backing and a clear mandate to act.
The brief:
- Act as the primary regulatory lead and interface with MHRA
- Stabilise the regulatory position following inspection feedback
- Build, formalise and implement GMP and regulatory processes
- Support readiness for publication and launch activity
- Work closely with senior leadership, lab and clinical teams
Required experience:
- Strong background in ATMPs / autologous stem cell therapies
- Hands‑on experience dealing directly with MHRA
- Deep GMP cell manufacturing expertise
- CQC experience is highly desirable
- Practical, delivery‑focused operator rather than advisory‑only
Engagement details:
- Start: ASAP
- Format: Full‑time consulting role
- Initial term: 3 months, with a strong view to extension
- Location: London
- Day rate is highly competitive (budget approved)
The right individual will be engaged immediately. This role is critical to the launch and is a good fit for someone comfortable working under pressure, with the credibility and judgement to manage regulators and implement change at pace.
If this sounds relevant, or you know someone suitable, please get in touch directly.
Regulatory Consultant - Cell & Gene Therapy in City of London employer: Valtera Group Ltd
Contact Detail:
Valtera Group Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Consultant - Cell & Gene Therapy in City of London
✨Tip Number 1
Network like a pro! Reach out to your connections in the cell and gene therapy space. Attend industry events or webinars, and don’t be shy about introducing yourself to potential employers. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ATMPs and GMP processes. We recommend practising common interview questions related to regulatory roles. Show them you’re not just a candidate, but the candidate they need to stabilise their regulatory position!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can go a long way. It shows your enthusiasm for the role and keeps you fresh in their minds. We believe this small gesture can make a big difference in landing that job.
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, we’re always looking for passionate individuals ready to take ownership in high-pressure environments like this one!
We think you need these skills to ace Regulatory Consultant - Cell & Gene Therapy in City of London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience with ATMPs and GMP processes. We want to see how your background aligns with the role, so don’t be shy about showcasing your hands-on experience with MHRA and CQC.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this high-pressure role. We love seeing enthusiasm and a clear understanding of the regulatory landscape in cell and gene therapy.
Showcase Your Achievements: When detailing your experience, focus on specific achievements that demonstrate your ability to stabilise regulatory positions and implement processes. We’re looking for practical examples that show you can deliver results under pressure.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity right away!
How to prepare for a job interview at Valtera Group Ltd
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of ATMPs and the specific regulations surrounding them. Familiarise yourself with the MHRA and CQC guidelines, as you'll need to demonstrate your expertise in these areas during the interview.
✨Showcase Your Hands-On Experience
Be ready to discuss your practical experience with GMP processes and how you've dealt directly with regulatory bodies like the MHRA. Prepare examples that highlight your ability to stabilise regulatory positions and implement effective changes under pressure.
✨Engage with Stakeholders
Since this role involves a lot of stakeholder engagement, think about how you've successfully collaborated with senior leadership and clinical teams in the past. Be prepared to share specific instances where your communication skills made a difference.
✨Demonstrate Your Delivery Focus
This position requires a practical, delivery-focused approach. Think of examples where you've had to act quickly and effectively to meet tight deadlines or manage high-pressure situations. Show that you're not just an advisor but someone who gets things done.