Farmaceutische Industrie: Vigilance and Regulatory
Il y a 7 mois
Voor ons klein maar supersympathiek team zijn we op zoek naar een nieuwe medewerker met een passie voor en interesse in farmaceutische wetgeving en vigilantie. Je helpt mee nieuwe geneesmiddelen en voedingssupplementen te registreren, hun marketing materiaal te bekijken en goed te keuren, en hun veiligheid te bewaken (farmacovigilantie), en dit voor Benelux en EU bedrijven. Een heel gevarieerde job
Idealiter heb je nog niet zo lang geleden de schoolbanken verlaten en ben je op zoek naar een gevarieerde job in de farmaceutische industrie. Je hebt een diploma farmaceutische wetenschappen (apotheker) of biomedische wetenschappen.
Je komt terecht in een dynamisch team, een mix van junior en meer ervaren collega's, die ernaar uitkijken jou veel te leren
We werken in een internationale omgeving waar veel engels (en ook frans) wordt gesproken en geschreven.
**Over Studio Pharma**:
Studio Pharma is een klein maar flexibel consultancybedrijf dat diensten aanbiedt aan de Europese farmaceutische industrie. Onze kantoren bevinden zich in de buurt van de prachtige oude stad van Gent.
Het Studio Pharma team heeft veel ervaring in verschillende domeinen (regelgeving, kwaliteit, vigilantie) en in verschillende productcategorieën (geneesmiddelen, voedingssupplementen, medische hulpmiddelen en cosmetica).
**Over de functie**:
Als RA/Vigilantie Officer kom je terecht in een klein team waarin de balans tussen werk en privé en een prettige en ondersteunende werkomgeving heel belangrijk is.
Je ondersteunt bij een divers scala aan projecten:
- Lokale farmacovigilantie activiteiten (adverse event handling, reconciliatie, literatuurscreening, medische vragen...)
- Deelnemen aan audits en vigilantie inspecties
- Opvolgen van regulatory intelligence en vigilantie-updates
- Compliance activiteiten (transparantie, Mdeon visumaanvragen, controle van promotiemateriaal...)
- Indienen en opvolgen van aanvragen en variaties voor geneesmiddelen
- Nationale BeNeLux-procedures: notificaties, CPP's (Certificaten van Farmaceutische Producten)
- Bijhouden van trackers voor regelgevende informatie
- Updates van geneesmiddeleninformatie (SKP, Bijsluiter, Etikettering, Artwork)
- Communicatie met lokale bevoegde instanties en Europese klanten
**Jouw profiel**:
We zijn op zoek naar een gemotiveerde en enthousiaste collega met een farmaceutische achtergrond (apotheker bij voorkeur), die beschikbaar is om zo snel mogelijk te starten, een open en ondernemende ingesteldheid heeft, met een goede kennis van het Engels en het Nederlands en indien mogelijk het Frans. Punctualiteit en kennis van Microsoft office tools zijn een basisvereiste.
Junior profielen met motivatie zijn ook welkom om te solliciteren
Deeltijds werken behoort tot de mogelijkheden.
We kijken ernaar uit je te ontmoeten
Dienstverband: Voltijds, Onbepaalde duur
Loon: €3.000,00 - €3.500,00 per maand
Werklocatie: Hybride telewerken in 9050 Gent
-
Regulatory Affairs Officer
Il y a 7 mois
Gent, Belgique Cooper Consumer Health Temps pleinRequisition ID - 39 - Job Family 1- Regulatory & PSRM - Country 1- Belgium - Location 1- Hybrid - About us - **Cooper Consumer Health** is a leading European consumer healthcare player that develops, produces, and distributes a diverse range of OTC (over-the-counter) products with strong brands such as Valdispert, Oenobiol, Excilor, Vitascorbol, Lashyle and...
-
Regulatory Associate
il y a 2 jours
Gent, Belgique Milliken and Company Temps pleinMilliken & Company werd opgericht in 1865 en is één van 's werelds grootste privé-ondernemingen in chemie - en textieltoepassingen. Wereldwijd werken meer dan 7000 Milliken collega’s samen op 45 locaties verspreid over Amerika, Europa, Afrika en Azië. We worden erkend als internationale leider op vlak van onderzoek, technologie, innovatie en...
-
Regulatory Affairs Specialist
il y a 2 jours
Gent, Belgique Nuwhï Temps pleinWe zijn op zoek naar een ervaren Senior Regulatory Affairs Specialist om ons team te versterken in regio Gent. In deze rol ben je verantwoordelijk voor het coördineren, implementeren en waarborgen van naleving van alle relevante wet - en regelgeving. Als Senior Regulatory Affairs Specialist ben je de expert in je vakgebied en zul je fungeren als interne en...
-
Regulatory Affairs Manager
il y a 5 jours
Gent, Belgique Nuwhï Temps plein**About the role** The Regulatory Affairs Manager is responsible for managing the lifecycle of the medicines from the preparation of the registration dossier, including the follow-up and finalization of new registrations, the preparation to market access, compilation, submission, and follow-up of variation dossiers in the Benelux. Basically the RA manager...
-
Associate Director/director, Regulatory
Il y a 7 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, argenx, based in Europe, to support the rapid growth needed for successful commercialization. Key Accountabilities and Responsibilities: The Associate Director/Director Regulatory Affairs is a key member of the global regulatory team. This role...
-
Regulatory Operations Lead
il y a 1 semaine
Gent, Belgique Argenx Temps pleinFor the expansion of our Regulatory Affairs team, argenx is looking for a Regulatory Operations Lead, who will lead global regulatory operational activities and manages the operational aspects of eCTD filings and other regulatory filings to Health Authorities. Key Accountabilities/Responsibilities: The position will have the following key...
-
Regulatory Data and Quality Management Officer
il y a 2 semaines
Gent, Belgique BASF Belgium Coordination Center Comm.V. Temps pleinAgriculture 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 control and landscape management - so that we can effectively contribute to improving people's lives and business' demands. Come join us on...
-
junior Regulatory Affairs Specialist
Il y a 9 mois
Gent, Belgique Elements Advisory Temps pleinAs a Junior Regulatory Affairs Specialist, you will be responsible for assisting in the management of regulatory affairs activities related to our biocide products. You will collaborate closely with the regulatory affairs team and other cross-functional departments to ensure compliance with relevant regulations and standards. **Responsibilities**: - Assist...
-
Regulatory Affairs Officer
Il y a 7 mois
Gent, Belgique Nuwhï Temps pleinDo you want to be an expert in **medical affairs** - **market access** and **regulatory affairs**? We have a great opportunity to be able to learn and to get an expert in these fields. The great thing about it, is that this mix of RA and Medical affairs or Market access is not that common in the field. This could be the reason why you as an RA professional...
-
Senior Regulatory Affairs Specialist
Il y a 9 mois
Gent, Belgique Elements Advisory Temps pleinAs a Senior Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for biocide products. You will work closely with cross-functional teams, regulatory authorities, and external partners to facilitate the registration and approval processes for biocide products in different markets. Your expertise in...
-
Head of Regulatory Affairs Emea
Il y a 4 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA. argenx argenx is a fast-growing global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Thanks to colleagues based in Europe, the United States and Japan, we translate immunology breakthroughs into a...
-
Associate Director/director Regulatory Affairs
il y a 2 jours
Gent, Belgique Argenx Temps pleinFor the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, based in Europe, to support the rapid growth needed for successful commercialization. The role will report into the Global Head of Regulatory Affairs. Key Accountabilities and Responsibilities: The Associate Director/Director Regulatory Affairs...
-
Head of Regulatory Affairs Emea
Il y a 8 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA. PURPOSE OF THE ROLE The Head of Regulatory Affairs, EMEA, is a key member of the global regulatory team as well as the EMEA Leadership Team (ELT). This role serves as a close business partner and facilitator of regulatory activities, and is expected to contribute...
-
Consumer Services Coordinator
Il y a 7 mois
Gent, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: As Consumer Services Coordinator you will be primarily responsible for the timely intake of quality or safety related customer cases coming in via various sources. In...
-
Regulatory Intelligence Mgr, Global Ra
Il y a 4 mois
Gent, Belgique Argenx Temps pleinRoles and Responsibilities: - Identify and permanently monitor the information needs of the internal stakeholders. - Participate in the external environment parsing, extracting relevant information. - Analyze and interpret changes to the regulatory landscape. - Keep up to date with latest guidelines from Health Authorities e.g.: EMA, MHRA, FDA, PMDA and...
-
Associate Cmc Regulatory Scientist
Il y a 7 mois
Gent, Belgique Ardena Temps plein**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...
-
Center of Excellence Regulatory Lead
il y a 2 jours
Gent, Belgique Argenx Temps pleinFor the expansion of our Regulatory team, argenx is looking for a Center of Excellence Regulatory Lead who is responsible for:- managing the team of regulatory associates that performs regulatory oversight for the individual studies. Key Accountabilities/Responsibilities: - Maintain an in-depth knowledge of the fast-evolving global clinical trial...
-
Head of Post-marketing Cmc Regulatory
Il y a 7 mois
Gent, Belgique Argenx Temps pleinKey Accountabilities and Responsibilities: Leads the CMC Regulatory Affairs function within post-marketing CMC. Provides strategic leadership to support development and execution of regulatory strategies for marketed products in the US, EU, Japan and roll-out to other territories world-wide. Critical to this role are strong CMC regulatory strategy and...
-
Senior Associate Regulatory Affairs
Il y a 7 mois
Gent, Belgique Perrigo Temps plein**Description Overview**: We are excited to be recruiting for an Senior Associate in Regulatory Affairs to be based in either Ghent, Rotterdam, London or Paris. Paris, France or Ghent working on our exciting Medical Device Portfolio. The main responsibilities of the role will be to work on a diverse range of Regulatory Affairs projects to meet business...
-
Senior Manager
Il y a 7 mois
Gent, Belgique BIVMB Temps plein**WHO ARE WE?**: At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 53,000 employees globally who nurture a diverse, collaborative, and inclusive culture. We believe that if we have...