Regulatory Affairs Manager
il y a 3 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.
#J-18808-Ljbffr-
Regulatory Affairs Manager
il y a 2 semaines
Gent, Flandre, Belgique Nuwhï Temps pleinVoor een toonaangevend farmaceutisch consultancybedrijf in de regio Gent, dat al 25 jaar actief is in de sector, zoeken we een ervaren Regulatory Affairs Manager. Over het bedrijf Dit dynamische team biedt hoogwaardig advies en gespecialiseerde diensten aan farmaceutische bedrijven, zowel nationaal als internationaal. Kwaliteit, integriteit en...
-
Senior Manager/Director of Regulatory Affairs
il y a 2 semaines
Gent, Flandre, Belgique Nuwhï Temps pleinVoor een toonaangevend farmaceutisch consultancybedrijf in de regio Gent, dat al 25 jaar actief is in de sector, zoeken we een ervaren Regulatory Affairs Manager. Over het bedrijf Dit dynamische team biedt hoogwaardig advies en gespecialiseerde diensten aan farmaceutische bedrijven, zowel nationaal als internationaal. Kwaliteit, integriteit en...
-
Regulatory affairs expert
il y a 1 semaine
Gent, Flandre, Belgique TN Belgium Temps pleinBen jij gepassioneerd door onderzoek en ontwikkeling van producten? Ben je klaar om bij te dragen aan innovatieve en kwaliteit van de productie en te werken in een dynamisch team? Dan is de functie van regulatory affairs expert wellicht iets voor jou.Een greep uit jouw toekomstig takenpakket:Het opvolgen van de evoluties van de verschillende wetgevingen.De...
-
Head of Regulatory Affairs
il y a 1 semaine
Gent, Flandre, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Head of Regulatory Affairs & Quality Benelux, East FlandersClient:Hudson BeneluxLocation:Job Category:OtherEU work permit required:YesJob Reference:6796c7c19005Job Views:2Posted:06.03.2025Expiry Date:20.04.2025Job Description:FunctionThe Head of Regulatory Affairs and Quality Assurance is a key member of our...
-
Regulatory Affairs Assistant
il y a 4 jours
Gent, Flandre, Belgique AGO Jobs & HR Temps pleinJe zoekt een toffe job? Tijdelijk of (optie) vast? Als arbeider of bediende? Kom dan zeker langs in een van onze 80 kantoren of surf naar Toon websitewww.ago.jobs. Wij hebben meer dan 3500 openstaande vacatures voor jou en helpen jou graag een job te vinden die bij jou past. Choose life, choose work, choose AGORegulatory Affairs...
-
Regulatory Affairs Associate, East Flanders
il y a 1 semaine
Gent, Flandre, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Regulatory Affairs Associate, East FlandersClient:PerrigoLocation:East FlandersJob Category:OtherEU work permit required:YesJob Reference:4814fac7087aJob Views:4Posted:06.03.2025Expiry Date:20.04.2025Job Description:Description OverviewWe have an exciting opportunity in our Central Regulatory Affairs team for a...
-
Head of Regulatory Affairs Seeds
il y a 1 semaine
Gent, Flandre, Belgique Basf venezolana, s.a. Temps pleinHead of Regulatory Affairs Seeds & Traits - EMEA (m/f/d)Agriculture plays a fundamental role in fulfilling many of humanity's basic needs: food, feed, energy. To support growers and those who take care of our environment, BASF develops innovative solutions for farming, pest-, disease- and weed control so that we can effectively contribute to improving...
-
International Regulatory Affairs Engineer
il y a 1 semaine
Gent, Flandre, Belgique TN Belgium Temps pleinInternational Regulatory Affairs Engineer, Oost-VlaanderenOost-Vlaanderen, BelgiumJouw job en verantwoordelijkheden :Je volgt, bestudeert en analyseert de ontwikkelingen in de Europese en internationale technische regelgeving en normen op de voet en ontwikkelt onderbouwde en tijdige Honda-standpunten, in nauw overleg met Honda-collegas in Research &...
-
Chemical Regulatory Affairs
il y a 2 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinFunctieomschrijvingEen regulatory affairs positie in een chemisch bedrijf vereist een diepgaande kennis van wet- en regelgeving in de chemische industrie, evenals sterke analytische, communicatie- en projectmanagementvaardigheden om ervoor te zorgen dat het bedrijf voldoet aan alle relevante voorschriften en normen.VerantwoordelijkhedenJe staat in voor de...
-
Gent, Flandre, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Regulatory Affairs Associate – Drive Your Career, GhentClient: NonStop ConsultingLocation:East FlandersJob Category:OtherEU work permit required:YesJob Reference:9ad6fd4bb05eJob Views:2Posted:06.03.2025Expiry Date:20.04.2025Job Description:Are you a scientifically-minded professional seeking a dynamic role where...
-
CMC Lifecycle Management Project Manager
il y a 3 semaines
Gent, Flandre, Belgique argenx Temps pleinargenx is a clinical & commercial stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique SIMPLE Antibody platform and suite of Fc engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates...
-
CMC Life Cycle Project Manager
il y a 3 semaines
Gent, Flandre, Belgique HR One Group Temps pleinA We are seeking a highly skilled and experienced Project Manager to oversee and manage the change control system within our biopharmaceutical company. This role is critical in ensuring compliance with CMC regulatory requirements, maintaining product quality, and facilitating efficient project execution. The ideal candidate will have a strong background in...
-
QA Project Manager
il y a 2 semaines
Gent, Flandre, Belgique MindCapture Temps pleinAls QA Project Manager speel je een cruciale rol in het waarborgen van de kwaliteitsborging van de projecten. Je leidt het team en zorgt ervoor dat alle processen voldoen aan de geldende regelgeving.Toezicht op naleving van GMP/ATMP-normen tijdens de productie.Ontwikkelen en implementeren van QA-strategieën en samenwerking met R&D, productie en regulatory...
-
Quality Assurance Labelling Manager
il y a 3 semaines
Gent, Flandre, Belgique Michael Page International (Belgium) Temps pleinQuality Assurance Manager - Labelling - EMEA - Medical DevicesHealthcare - Lifesciences - Quality - People Management - Flanders - DU/ENGAbout Our ClientOur client is a large multinational medical devices company leader in the life science industry with over 10,000 employees worldwide. The company is renowned for innovative solutions that contribute to...
-
Gent, Flandre, Belgique TN Belgium Temps pleinSocial network you want to login/join with:RA Manager – Growth Opportunity in Healthcare Industry, GhentClient: NonStop ConsultingLocation:East FlandersJob Category:OtherEU work permit required:YesJob Reference:a760c95b057bJob Views:2Posted:06.03.2025Expiry Date:20.04.2025Job Description:Are you ready to embark on a dynamic journey in the world of consumer...
-
Project manager R&D
il y a 1 semaine
Gent, Flandre, Belgique TN Belgium Temps pleinFunctieomschrijvingWat zijn jouw taken als Project Manager R&D?Het ontwikkelen van detergenten, hygiëne middelen en reinigingsprocessen voor professioneel gebruik.Je staat in voor de ontwikkeling en optimalisatie van testmethoden en analytische technieken om productontwikkeling te ondersteunen.Je werkt nauw samen met de Regulatory Affairs collega's.Je...
-
RA Global Strategy Manager
il y a 1 jour
Gent, Flandre, Belgique NonStop Consulting Temps pleinOur client, a global pharmaceutical organization, is currently looking for a Regulatory Global Strategy Manager for their office in Ghent. They are going through a period of rapid expansion, making it an ideal time for professionals looking for growth opportunities to join the team. Benefits: - Opportunity to work with a highly experienced international...
-
Quality Manager TN Benelux, Ghent
il y a 3 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinFunctieomschrijvingOur client is focused on 'Feeding the Future' through sustainable practices, with two business lines: Skretting, a global leader in aquafeed solutions, and a focus on advancing livestock health via innovative nutrition.As Quality Manager Benelux, you ensure continuous improvement in quality management systems, meeting customer, authority,...
-
R&D Manager, East Flanders
il y a 1 semaine
Gent, Flandre, Belgique TN Belgium Temps pleinQui recherchons-nous ?Qu'est-ce que nous vous offrons ?Chèques-repasIndemnité kilométriqueIntroductionEn heb je een passie voor chemie?En hou je ervan om nieuwe producten te ontwikkelen?Dan ben je bij SD Worx Jobs aan het goede adresQui recherchons-nous ?Je hebt al enkele jaren ervaring in een leidinggevende functieJe hebt een masteropleiding in een...
-
R&D Manager
il y a 3 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinKonvert Office zoekt een ervaren R&D Manager voor een succesvolle Belgische multinational die actief is in reinigingsproducten voor de gezondheidszorg, textiel- en voedingsindustrie. Het bedrijf onderscheidt zich op de markt door haar uitmuntende service en door in te zetten op innovatie.Vanuit het hoofdkantoor in Gent zal je:Aan de leiding staan van het New...