Director Regulatory Affairs* (Reporting to Vice President Regulatory Affairs)

Your mission

As US Director Regulatory Affairs, you will develop and execute regulatory strategies to advance our anti-infective portfolio through all stages of development (early to late phase). As a member of the regulatory affairs team, your key responsibilities will be to support/co-lead the NDA for our most advanced asset in close collaboration with the cross-functional Pritelivir project team. The US Director Regulatory Affairs will provide expertise in translating regulatory requirements into practical plans and will facilitate/lead authority meetings with respect to document preparation and meeting discussions as well as guiding the cross-functional project team. The position, based in the US (remote), will require working with a team located mainly in Europe and will therefore require both flexibility and the ability to work in an international environment. The US Director will report to the Vice President Regulatory Affairs and will be a core member of a small but agile regulatory team.

Responsibilities

• Support/co-lead new drug application (NDA) in the US (dossier preparation, interaction with FDA, responses to questions) to ensure regulatory approval.
• Once the product is approved for marketing, provide the necessary support to ensure compliance with local regulatory requirements.
• Act as the contact point for FDA across the AiCuris portfolio.
• Contribute to the development of clinical regulatory plans and strategies, identify and propose risk mitigation strategies, and influence project teams and sub-teams across international site locations.
• Plan, coordinate, and supervise all types of submissions to FDA for assigned products/projects.
• Provide strategic/hands-on support for the various compounds of the portfolio as well as potential line extensions.
• Provide regulatory assessment during due diligence.
• Maintain up-to-date knowledge of highly complex regulatory requirements and communicate changes to project teams.
• Contribute to internal regulatory policies and procedures to achieve best practices and work processes.

Your profile

• Advanced academic degree in natural sciences.
• At least 10 years of regulatory experience in the pharmaceutical industry/biotech including direct experience in leading an NDA in the US.
• Proficiency in preparing and submitting regulatory documents, including INDs to regulatory authorities, with a thorough understanding of regulatory submission requirements and processes.
• Ability to identify regulatory risks and opportunities, proactively assess their potential impact on regulatory approval or compliance, and develop mitigation strategies to address them effectively.
• Familiarity with OPDP requirements is a plus, as well as post-marketing experience.
• Experience within the antiviral/anti-infectives therapeutic area is a plus.
• Good organizational, communication, and intercultural skills.
• Excellent teamwork skills.
• Continuous striving for innovative thinking and operational excellence.
• Capable of adapting to changes creatively, and ability to remain focused in complex situations.
• Strong leadership skills with the ability to effectively lead and motivate a multidisciplinary team, foster collaboration, and drive results in a fast-paced and dynamic environment.
• Lead by example, demonstrate company values, and foster an environment of transparent and effective communication.

Why us?

• Unique corporate culture: Scientific excellence, a collaborative working environment, and the passion to improve the lives of patients define our work. You can work together with innovation-awarded experts with the proven ability to translate science into commercial success. Expect diversity, inspiration, and trustful collaboration.
• Development: We encourage people to grow and strongly support individual development and learning opportunities.
• Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal lives.
• Benefits: Competitive comprehensive benefit plan.

About us

AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS, marketed by our partner MSD, treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.

Passionate about our mission to develop anti-infective therapeutics for patients in need, a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other's personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn.

AiCuris is an employer that supports equal opportunities, diversity, and inclusion. We welcome applications from people regardless of their national origin, skin color, religion, gender, age, marital status, disability, sexual orientation, gender identity, or other legally protected characteristics.