SpliceBio is a biotechnology company developing the next generation of genetic medicines through its proprietary Protein Splicing platform. Our mission is to unlock the potential of gene therapy by enabling the delivery of therapies beyond the size limitations of conventional approaches, with the goal of addressing diseases with significant unmet medical need.

Built on more than 20 years of pioneering research in inteins and protein engineering from the Muir Lab at Princeton University, SpliceBio is headquartered in Barcelona and operates in a highly collaborative, international environment.

The Role
As Regulatory Affairs Manager, you will play a key role in shaping and executing regulatory strategies across our development programs. Working closely with the VP of Regulatory Affairs & Quality Assurance and cross-functional teams, you will drive integral regulatory activities, support interactions with health authorities, and help advance innovative gene therapies for patients with high unmet medical needs.




This role supports the company's gene therapy development programs and contributes to interactions with the FDA, EMA and other Regulatory Authorities.

Main Responsabilities
1. Regulatory Strategy & Submissions
- Ensure that the content, quality and format of regulatory submissions comply with applicable regulations and guidelines.
- Drive the preparation of regulatory applications, including Orphan Drug Designation applications, INDs/CTAs, Scientific Advice procedures, Paediatric Investigation Plans (PIPs), and NDAs/MAAs.
- Support the development and execution of regulatory strategies that facilitate successful product development and registration.

2. Regulatory Authority Interactions
- Manage and coordinate interactions with internal and external stakeholders, including the EMA, FDA and other Regulatory Authorities, on behalf of the company.
- Contribute to the preparation of regulatory meetings and responses to agency requests.

3. Development Strategy Input

📌 Regulatory Affairs Manager (Cataluña)
🏢 SpliceBio
📍 Cataluña