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- Tasks: Lead regulatory strategies for innovative stem cell therapies and oversee global submissions.
- Company: Join a cutting-edge biotech firm focused on transformative treatments for degenerative diseases.
- Benefits: Enjoy a competitive salary, hybrid work options, and various corporate perks.
- Why this job: Shape the future of healthcare while working in a dynamic, impactful environment.
- Qualifications: PhD preferred; 10+ years in Regulatory Affairs with a focus on advanced therapies required.
- Other info: Mentor a small team and engage directly with global regulators.
The predicted salary is between 104000 - 136000 £ per year.
Location: London, UK (Hybrid)
Salary: £125-160K, plus multiple benefits including LTIP.
Executive Recruitment are again partnering with a cutting-edge biotech company specialising in stem cell therapies aimed at treating degenerative diseases. With a pipeline of promising products and strong investor backing, we are seeking an experienced Regulatory Affairs leader to drive strategy and navigate global regulatory landscapes.
Key Responsibilities- Lead the Regulatory Affairs function for late-stage stem cell and advanced therapy products.
- Develop and execute regulatory strategies across the UK, EU, and the US.
- Oversee regulatory submissions: CTAs/INDs, RMAT/PRIME designations, MAA/BLA filings.
- Coordinate with cross-functional teams to ensure compliance and alignment.
- Serve as primary liaison with regulators (MHRA, EMA, FDA); represent the company in meetings.
- Mentor and manage a small RA team (3-5 professionals).
- Keep abreast of evolving stem cell/ATMP regulations and ensure internal readiness.
- Degree in life sciences; PhD preferred.
- Minimum 10 years in Regulatory Affairs within biotech/pharma, with advanced therapies (stem cell focus) strongly preferred.
- Proven track record in global submissions and regulatory wins.
- Strong leadership, strategic insight, and communication skills.
The Regulatory Affairs Director will play a pivotal role in shaping the future of the business on a global scale, ensuring compliance and the adaptiveness for growth and scale across multiple continents. If you have the skills, experience and gravitas to lead and educate within this role then please do not hesitate to apply.
Regulatory Affairs Director employer: Executive Recruit
Contact Detail:
Executive Recruit Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Director
✨Tip Number 1
Network with professionals in the biotech and regulatory affairs sectors. Attend industry conferences, webinars, and local meetups to connect with key players and learn about potential opportunities.
✨Tip Number 2
Stay updated on the latest regulations and guidelines related to stem cell therapies and advanced therapies. This knowledge will not only enhance your expertise but also demonstrate your commitment to the field during interviews.
✨Tip Number 3
Consider reaching out to current or former employees of the company to gain insights into their culture and expectations. This can help you tailor your approach and show that you understand their specific needs.
✨Tip Number 4
Prepare for interviews by practising how to articulate your past successes in regulatory submissions and leadership roles. Use specific examples that highlight your strategic thinking and ability to navigate complex regulatory environments.
We think you need these skills to ace Regulatory Affairs Director
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs, especially within biotech and advanced therapies. Emphasise any specific achievements related to global submissions and regulatory compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your leadership skills and strategic insight. Mention your familiarity with regulations from MHRA, EMA, and FDA, and how you can contribute to the company's goals.
Highlight Relevant Experience: In your application, focus on your past roles that involved mentoring teams and developing regulatory strategies. Provide examples of successful regulatory submissions you've led.
Showcase Continuous Learning: Mention any recent training or courses you've taken related to stem cell therapies or advanced therapy medicinal products (ATMPs). This shows your commitment to staying updated in the field.
How to prepare for a job interview at Executive Recruit
✨Showcase Your Regulatory Expertise
Make sure to highlight your extensive experience in Regulatory Affairs, especially within biotech and advanced therapies. Be prepared to discuss specific examples of successful submissions and how you navigated complex regulatory landscapes.
✨Demonstrate Leadership Skills
As a Regulatory Affairs Director, you'll be leading a team. Share your experiences in mentoring and managing teams, and provide examples of how you've fostered collaboration across cross-functional groups to achieve compliance.
✨Stay Updated on Regulations
Familiarise yourself with the latest developments in stem cell and advanced therapy regulations. During the interview, mention any recent changes you've adapted to and how you ensure your team stays informed and compliant.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world scenarios. Think about challenges you've faced in previous roles and how you overcame them, particularly in relation to regulatory submissions and interactions with agencies like the MHRA, EMA, and FDA.
