Product Lead, Regulatory Innovation & Development

Job Title: Product Lead, Regulatory Innovation & Development

Job Type: Full-time, Permanent Position

Location: West London, UK

Remuneration: Competitive salary and package

Check you match the skill requirements for this role, as well as associated experience, then apply with your CV below.

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.

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.

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.

Key Responsibilities

• Drive AI-enabled regulatory and development strategies across global programmes.
• Influence development programs through AI innovation, clinical development, operations, regulatory compliance, and commercialisation.
• Hands-on with QMS improvement and full GxP compliance.
• Support CTA, IND, IMPD, MAA and broader regulatory submission activities.
• Lead cross-functional programmes spanning Regulatory Affairs, Quality, Clinical Development and AI teams.
• Partner with scientific and technical stakeholders to translate innovative methodologies into regulator-ready evidence packages.
• Engage with global health authorities, including FDA, EMA and MHRA.
• Develop scalable, risk-based quality and governance frameworks to support innovation.

Requirements

• Significant experience within biotech, pharma, or advanced therapeutics.
• Hands-on AI-related experience and confidence in influencing AI policy and frameworks.
• Strong understanding of drug development and global regulatory pathways.
• Experience supporting CTA, IND, IMPD, and marketing application activities.
• Hands-on experience with GxP, Quality Systems and regulatory compliance.
• Ability to work effectively across AI, scientific, regulatory and development teams. xwzovoh
• Experience within gene therapy, AAV, neuroscience or CNS programmes is highly desirable.

For more information, please contact