Product Lead, Regulatory Innovation Development

p strong Job Title: /strong Product Lead, Regulatory Innovation Development /p p strong Job Type: /strong Full-time, Permanent Position /p p strong Location: /strong West London, UK /p p strong Remuneration: /strong Competitive salary and package strong /strong /p p br /p p Cpl Life Sciences is partnering with a stealth-mode AI biotech operating at the intersection of AI and drug development, with a focus on AAV, CNS and neurological disease programmes. /p p br /p p This is a unique opportunity to lead the development and implementation of AI-enabled approaches across Regulatory, Quality and Development functions, supporting innovative therapeutic programmes from early development through to registration. /p p br /p p This position is the first of this type into the business so are looking for a very experience professional with ideally both drug development and Ai related experience.

This role is part of the AI innovation leadership team. /p p br /p p strong u Key Responsibilities /u /strong /p ul li Drive AI-enabled regulatory and development strategies across global programmes. /li li Influence development programs through AI innovation, clinical development, operations, regulatory compliance, and commercialisation. /li li Hands-on with QMS improvement and full GxP compliance. /li li Support CTA, IND, IMPD, MAA and broader regulatory submission activities. /li li Lead cross-functional programmes spanning Regulatory Affairs, Quality, Clinical Development and AI teams. /li li Partner with scientific and technical stakeholders to translate innovative methodologies into regulator-ready evidence packages. /li li Engage with global health authorities, including FDA, EMA and MHRA. /li li Develop scalable, risk-based quality and governance frameworks to support innovation. /li /ul p br /p p strong u Requirements /u /strong /p ul li Significant experience within biotech, pharma, or advanced therapeutics. /li li Hands-on AI-related experience and confidence in influencing AI policy and frameworks. /li li Strong understanding of drug development and global regulatory pathways. /li li Experience supporting CTA, IND, IMPD, and marketing application activities. /li li Hands-on experience with GxP, Quality Systems and regulatory compliance. /li li Ability to work effectively across AI, scientific, regulatory and development teams. /li li Experience within gene therapy, AAV, neuroscience or CNS programmes is highly desirable. /li /ul p br /p p For more information, please contact lucy.kirkaldy@cpl.com /p

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