Company Description
Bactolife is a Danish biotech firm committed to enhancing global gut health through innovative food ingredients called Binding Proteins. They selectively bind and neutralize unhealthy metabolites while preserving the beneficial microbiome, and can be used in food, beverages, and supplements. Our solutions cater to diverse needs, including mothers, children, the elderly, immune-compromised individuals, travelers, and even animals. Backed by prominent investors like Novo Holdings, the Bill & Melinda Gates Foundation, and Innovation Fund Denmark, Bactolife strives to make Binding Proteins widely available to support gut health worldwide.
Role Description
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.
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.
Key Responsibilitites
- 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
- 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
