We are looking for a Regulatory Director (m/f/d)

Time commitment: min. 60% – Location: Zürich, Switzerland – Start: as soon as possible

At cellvie, we are leveraging the therapeutic potential of mitochondria, which will likely be regulated as a biologic. Based on augmentation and replacement, an approach developed at Harvard, we are building a medicinal platform, with first applications in heart attack patients and organ transplant recipients. cellvie is a venture-backed start-up with primary activities in Zurich.

We are looking for a highly motivated, diligent and pragmatic regulatory expert. You should have at least 8 years of experience in bringing biological medicinal products to market – ideally having worked with or in an early stage company. Tolerance for ambiguity and the capacity to self-sufficiently acquire new knowledge in your as well as in adjacent fields are indispensable.

What we are offering:

• The role of Regulatory Director, working directly with the company's founders and leadership team
• The chance to work on the development of a novel treatment modality - mitochondria
• Great responsibilities and degrees of freedom to develop and execute cellvie's regulatory strategy
• A varied task environment extending beyond regulatory submissions – e.g. to supporting the development of a quality management system and a GMP manufacturing process
• A highly dynamic and entrepreneurial environment
• Competitive pay and equity package

Who we are seeking:

You are expected to be self-motivated and resourceful, and as apt at efficiently applying your knowledge as you are in extending it. You should have ample experience in bringing biological products towards approval and ideally, you have already worked in an early-stage company. Experience in QMS and GMP and GLP would be valued.

Key qualities:

• In-depth knowledge in pursuing regulatory approval for biological medicinal products
• Ability to work independently and truly drive the approval-relevant activities
• Being well-organized and diligent, with a healthy pragmatism to make decisions under ambiguity
• The openness and ability to acquire new knowledge
• A talent for writing

Other qualities

• Full proficiency in English
• Experience in QM

Who we are:

• cellvie is a venture-backed biotechnology start-up, bringing about mitochondria-based therapies
• We are a team of like-minded individuals, passionate about our technology and the problems we seek to solve
• We are eager to go the extra mile and take pride in and joy from our work
• We have shown the safety and efficacy of our therapy in pre-clinical studies and in a first clinical pilot and are now focusing on the commercial translation of the technology in a variety of fields

Contact: Alex Schueller at jobs@cellvie.de