Terafront Farmatech is a public-private company focused on advancing research and development of innovative, accessible advanced therapies. Established in 2024 under Spain’s PERTE for Vanguard Health, Terafront unites the Spanish Ministry of Science, Innovation and Universities (through CDTI Innvierte) with global pharmaceutical companies ROVI and Insud Pharma. This collaboration leverages scientific excellence, industrial capacity, and institutional support to strengthen Spain’s position in advanced medicine. Terafront selects and supports high-potential projects that can translate scientific innovation into therapies with tangible benefits for patients and real-world clinical use. With a global perspective and a strong commitment to social impact, the organization works to broaden access to cutting-edge healthcare and drive the growth and international competitiveness of Spain’s life sciences ecosystem.

Terafront is seeking an experienced Head of Regulatory Affairs to lead the regulatory strategy for innovative therapies targeting rare diseases. This is a critical leadership appointment within a growing advanced therapies company. The successful candidate will define and execute the regulatory pathway from the current development package through Clinical Trial Application readiness and first-in-human clinical development.

This role requires more than coordinating documentation. It calls for a regulatory leader capable of integrating quality, nonclinical, clinical and environmental requirements into one coherent and defensible development strategy.

The role

Reporting directly to the CEO, the Head of Regulatory Affairs will take ownership of Terafront’s regulatory strategy and act as the principal regulatory interface with AEMPS and, subsequently, EMA and other relevant authorities. Will work closely with the Head of CMC & Technical Operations, clinical and nonclinical experts, researches, CDMO, and the cell-manufacturing facility, clinical investigators and external regulatory partners.

Key resposibilities

- Conduct a comprehensive regulatory gap assessment of the existing development package.
- Define and maintain the European regulatory strategy for the programs through Phase I and subsequent development.
- Lead interactions with AEMPS, including scientific and regulatory advice, and prepare future engagement with EMA and the Committee for Advanced Therapies.
- Coordinate the preparation,



review and submission of the Clinical Trial Application.
- Lead the development and management of the IMPD, Investigator’s Brochure, clinical-trial documentation and associated regulatory responses.
- Ensure effective integration of the IMPD quality, nonclinical and clinical sections.
- Incorporate GMO, environmental-risk and Spanish biosafety requirements into the development plan and submission schedule.
- Confirm and manage the orphan-designation strategy.
- Define the pediatric regulatory pathway, including the future Investigation Plan.
- Ensure that long-term follow-up requirements for an gene therapy product are appropriately addressed.
- Establish clear document ownership, review and approval responsibilities across Terafront and its development partners.
- Implement regulatory intelligence, submission planning and document-control processes suitable for a development-stage ATMP company.
- Identify regulatory risks early and translate them into clear mitigation actions, owners and timelines.
- Ensure that the CMC, nonclinical and clinical programs present one consistent scientific and regulatory narrative.
- Provide clear regulatory recommendations and progress updates to the CEO and Board.

Candidate profile

We are looking for a senior regulatory professional with substantial hands-on experience in the development of gene therapies, cell therapies or other advanced therapy medicinal products.

The idóneo candidate will bring:

- Approximately 10 - 15 years or more of experience in regulatory development within the biotechnology or pharmaceutical industry.
- Several years of direct responsibility for gene therapy, cell therapy or ATMP programs.
- Leadership of at least one European CTA for a genetically modified cell product or comparable gene-therapy program.
- Hands-on experience interacting with AEMPS and, preferably, EMA and the Committee for Advanced Therapies.
- Practical experience preparing and reviewing IMPD quality, nonclinical and clinical documentation.




- A strong understanding of the regulatory interdependencies between CMC development, nonclinical evidence and clinical-trial design.
- Familiarity with GMO authorizations, environmental-risk assessments and the Spanish biosafety framework.
- Knowledge of orphan designation, pediatric development and long-term follow-up requirements for integrating vectors.
- Experience managing responses to regulatory questions and coordinating multidisciplinary submission teams.
- The ability to interpret complex scientific and manufacturing information and challenge assumptions constructively.
- Excellent judgement, communication, negotiation and project-management capabilities.
- A pragmatic and entrepreneurial approach suited to a small biotechnology company operating through an external partner network.

Experience focused primarily on marketed conventional medicines or small-molecule lifecycle management, without meaningful development-stage ATMP exposure, would not provide the specialist background required for this position.

What will define success

During the initial stage, success will mean:

- Completing the regulatory gap assessment of the existing program/s.
- Establishing an integrated regulatory roadmap through Phase I CTA submission.
- Confirming the applicable AEMPS, GMO, orphan and pediatric requirements.
- Aligning the quality, nonclinical and clinical development plans.
- Establishing effective regulatory governance and document ownership across all partners.
- Delivering a coherent, high-quality and submission-ready CTA package.
- Anticipating regulatory risks early enough to prevent avoidable program delays.

Why join Terafront

This is an opportunity to shape the regulatory strategy of potentially transformative therapies for patients with severe rare diseases while helping to build a new European advanced therapies company.

The successful candidate will have significant responsibility, direct access to senior decision-makers and the opportunity to establish Terafront’s regulatory function from its foundations.

Location: Madrid, Spain

Employment model: Full-time

Reporting to: Chief Executive Officer

Interested candidates may apply through LinkedIn or contact us at [email protected] a CV and a brief description of their relevant ATMP development experience.

Terafront is committed to equal opportunity and welcomes applications from suitably qualified candidates.

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📌 Head of Regulatory Affairs - Advanced Therapies (Madrid)
🏢 Terafront
📍 Madrid