Regulatory Affairs Manager

✅ BSc in a scientific discipline (MSc preferred)

✅ 5-10 years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry

✅ Proven experience with EU and US regulatory submissions

✅ Strong understanding of the European and US regulatory landscape

✅ Experience in gene therapy is highly desirable. We also welcome candidates with backgrounds in cell therapy, biologics, or small molecule development

✅ Experience working in rare diseases

✅ Knowledge of gene therapy regulatory requirements, including GMO regulations, containment requirements, and long-term follow-up protocols, is a strong advantage

✅ Exposure to ophthalmology programs is a plus

✅ Experience with Chinese regulatory authorities and submissions is considered an asset

✅ Strategic mindset with the ability to assess and mitigate regulatory risks throughout drug development

✅ Strong communication and stakeholder management skills, with the ability to collaborate effectively across multidisciplinary teams

✅ Fluent English required (written and spoken); Spanish is a plus

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 global 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.

• 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.

• 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.

• Contribute to the design and execution of development strategies, with a particular focus on regulatory considerations, for assigned products.

• Develop and maintain Regulatory Affairs systems, processes and procedures to support regulatory submissions, approvals and regulatory intelligence activities.

• Monitor the evolving regulatory landscape, particularly within gene therapy, rare diseases and ophthalmology.

• Communicate relevant regulatory updates and their potential impact across the organization.

• Promote effective collaboration across Regulatory Affairs and multidisciplinary development teams, including CMC, Clinical and Preclinical functions.

• Provide regulatory guidance to support key project decisions and milestones.

• Project manage and/or support regulatory activities in the EU, US and other international markets in partnership with local consultants and regulatory specialists.