Regulatory Affairs Manager
il y a 2 semaines
We are looking for a Regulatory Affairs Manager to join our Inbiose team in Ghent (Belgium).
About Inbiose:
Inbiose is a spin-off company from Ghent University specialized in the development of innovative health products through biotechnology, 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 significantly over the next years. More information about Inbiose can be found on www.inbiose.com.
Position Overview:
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 for novel foods, GRAS, or food supplements.
In this role, you will oversee all regulatory activities within the company and apply for regulatory approval for our products worldwide. You will also manage a small team, providing leadership and support.
Qualifications & Experience:
- Education: A PhD or Master's degree in Life Sciences (e.g., Food Chemistry, Chemistry, Toxicology, or related field). Experience in Toxicology and knowledge of OECD guidelines 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 foods 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.
- Be a main contact person and collaborate with other internal teams, including R&D, quality, and legal, to ensure that regulatory strategies align with the company strategies and goals.
- Stay up-to-date and follow up on relevant regulatory updates or new legislation.
- Advise the company on regulatory strategies.
We offer:
We offer an interesting job with a lot of variety and responsibilities within a young, dynamic team of collaborators in a rapidly expanding field of the future. You will interact with motivated and open colleagues with different backgrounds.
In this position, you will receive an attractive salary, complemented by fringe benefits in line with market standards. You will work a 40-hour week, which entitles you to 12 compensation days (ADV). There is also the possibility of remote work from time to time.
The workplace is located at Technology Park 82 b41 in Ghent-Zwijnaarde, Belgium, easily reachable by car, bike, or public transportation.
Interested in this job? Send us your CV with a motivation letter to Gilles Jonckheere, Inbiose NV, Technologie Park 82 bus 41, 9052 Zwijnaarde, or via e-mail to jobs@Inbiose.com.
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