Senior Scientific and Regulatory Affairs Expert
The opportunity
If you are as ambitious as the rest of us and are dreaming of taking products to market in an entirely new field, this could be the role for you. This is a newly created position, giving you the opportunity to make a tangible impact in bringing Bactolife’s innovative products to the functional ingredient market.
Background
Bactolife is developing a platform of novel food ingredients, called Binding Proteins, which target and neutralize unhealthy metabolites in the gastrointestinal tract. These proteins can be incorporated into a broad range of products, from dietary supplements to medical nutrition, food & beverage products, hydration solutions and infant formulas.
Bactolife is launching its first product in 2026 with the US as the first market. The focus will initially be on Healthcare Professional players in the US to establish a strong presence among key influencers. From 2027 onwards, Bactolife will expand into mass market through large and strategic partnerships.
Bactolife is looking for an experienced scientific and regulatory affairs expert to support the commercialization of Bactolife’s Binding Proteins globally. You will be responsible for the regulatory work in ensuring market access for our functional precision-fermented Binding Protein ingredients in different Asian countries.
Key responsibilities
Joining Bactolife at this stage of growth means working in a dynamic environment where responsibilities will evolve alongside the company. As an expert, you will leverage your professional judgment and subject-matter expertise across strategy, planning, analysis, and operational execution. The role requires flexibility, collaboration, and the ability to contribute at both tactical and operational levels, a mindset shared across the organization as we scale.
Identify and work with expert consultants from the Asia-Pacific region
Prepare food ingredient dossier submission, registration, and renewal strategies for products within the region to gain and maintain market access
Support local consultants in engaging with key external stakeholders and local authorities in pre- and post-submission meetings
Understand and guide health claim options and substantiation hereof for different consumer product categories such as health/dietary supplements
Conduct compliance reviews and provide daily support to the business development team in preparing and executing customer pitches and dialogues
You are also expected to support the regulatory tasks/questions to EU novel food approvals, our business development as well as our clinical research activities
Qualifications and experience
Collaborative team player with a proven ability to build and maintain strong, long-lasting relationships
Result- and solution-oriented, with a genuine interest in supporting business development
10+ years’ experience within Regulatory Affairs or related areas, preferably with vast experience from the food tech and/or consumer health space
Experience with precision-fermented/GMM-derived ingredients dossier preparation and approval
Good understanding of Novel Food regulations in EU and/or in the Asia-Pacific region
Excellent communication skills and the ability to connect with external stakeholders such as expert consultants, customers and authorities
Good project management skills and attention to detail
Experience with claims in labelling and advertising is a plus
MSc or PhD in a relevant field, Biotechnology, Biology, Chemistry, Microbiology, Nutrition or other related scientific disciplines
- Department
- Regulatory & Clinical
- Locations
- Copenhagen
Copenhagen
About Bactolife
We are on a mission to enhance global gut health and support the fight against antimicrobial resistance.
As a Danish biotech firm, we are pioneering the future of gut health with our unique food ingredient, Binding Proteins.
Binding Proteins are natural and versatile enough for any food, beverage, or supplement, selectively bind and block harmful microbial activity without disturbing the beneficial microbiome.
Our food ingredients are specially formulated for diverse needs, benefiting everyone from mothers and children to the elderly, immune-compromised individuals, travelers, and even animals. Backed by investors such as Novo Holdings, the Bill & Melinda Gates Foundation, and Innovation Fund Denmark, we are committed to making Binding Proteins widely available. Our vision is a future where these proteins are a common part of diets, supporting gut health globally.
Our deep understanding of Binding Proteins, combined with competitive pricing, enables us to make these innovations accessible.
Join us as we change the future of gut health one Binding Protein at a time.