Regulatory Affairs Director

Regulatory Affairs DirectorLocation: London, UK (Hybrid)Salary : £125-160K, plus multiple benefits including LTIP.The RoleExecutive 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, were seeking an experienced Regulatory Affairs leader to drive strategy and navigate global regulatory landscapes.Key ResponsibilitiesLead 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 (35 professionals).Keep abreast of evolving stem cell/ATMP regulations and ensure internal readiness.Essential Qualifications & ExperienceDegree 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.TPBN1_UKTJ