Regulatory Affairs Manager
We are seeking an experienced Regulatory Affairs Manager with a strong scientific and regulatory background to join our growing regulatory team. The ideal candidate will have a solid understanding of regulations and regulatory submission processes related to novel foods, GRAS, or food supplements. In this role, you will be responsible for overseeing all regulatory activities within the company and applying for regulatory approval for our products worldwide. You will also manage a small team, providing leadership and support.
RegulatoryAbout Inbiose
Inbiose is a spin off company from Ghent University specialized in the development of innovative health products through biotechnology, more specifically human milk oligosaccharides. We are building towards an international health ingredient company, commercially rolling out our products internationally. At this time 50 people are working at Inbiose and the number of collaborators will expand over the next years significantly.
Qualifications & Experience
Education
- PhD or Master’s degree in Life Sciences (e.g., Food Chemistry, Chemistry, Toxicology, or a related field)
- Experience in Toxicology and knowledge of OECD guidances is a strong plus
Experience
- At least 5 years of experience in Regulatory Affairs
- Experience in monitoring or overseeing safety studies is highly desirable
- Proven experience in managing a team
- Strong understanding of global regulatory requirements for food, novel food, food supplements, GRAS, and other regulations
- Experience in submission of novel food or food-related applications to EFSA and FDA is an asset
- Experience in evaluating safety data and performing risk assessments is an asset
- Excellent written and verbal communication skills in English
- Proactive approach to problem-solving
Key Responsibilities
- Manage and coach a team and a network of consultants
- Lead and manage all regulatory affairs activities, ensuring compliance with international regulations
- Oversee the preparation and submission of regulatory filings to regulatory bodies
- Ensure timely communication with regulatory agencies regarding the progress of submissions and approvals
- Conduct scientific assessments of (toxicology) safety data to support regulatory submissions
- Monitor and review safety studies to ensure compliance with regulatory requirements
- Act as a main contact person and collaborate with internal teams, including R&D, quality, and legal, to ensure regulatory strategies align with company goals
- Stay up to date with relevant regulatory updates and new legislation
- Advise the company on regulatory strategies
We Offer
We offer an interesting position with a lot of variety and responsibilities within a young, dynamic team in a rapidly growing field of the future. You will work alongside motivated and open colleagues from diverse backgrounds.
- An attractive salary, complemented by fringe benefits in line with market standards
- A 40-hour work week, entitling you to 12 compensation days (ADV)
- Flexibility for remote work from time to time
- A modern workplace located at:
Technology Park 82 bus 41, 9052 Zwijnaarde, Ghent, Belgium, easily reachable by car, bike, or public transport
Interested?
Send your CV along with a motivation letter to:
Gilles Jonckheere 📧 Email: jobs@Inbiose.com
Strain Engineer - Lab informatics
You will have a dual role combining wet-lab activities and IT. You will be part of the strain engineering team, responsible for the development of new production hosts for specialty carbohydrates. You will work in the lab and use molecular biology techniques to create novel strains, but at the same time, you will be responsible for the different IT tools related to lab workflows. You will maintain and further enhance in-house developed tools and applications used by all people in the strain engineering team, and provide training and support.
Regulatory Affairs Manager
We are seeking an experienced Regulatory Affairs Manager with a strong scientific and regulatory background to join our growing regulatory team. The ideal candidate will have a solid understanding of regulations and regulatory submission processes related to novel foods, GRAS, or food supplements. In this role, you will be responsible for overseeing all regulatory activities within the company and applying for regulatory approval for our products worldwide. You will also manage a small team, providing leadership and support.