Regulatory Affairs Manager
il y a 5 jours
**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 ensures quality delivery of regulatory activities for the BeNeLux market. Regulatory activities include but are not limited to:
- Submission of new MAA, life cycle management activities (submission and follow up for variations, renewals, MAH transfer and withdrawal), interaction with health authorities on behalf of customers.
- Compilation, or supervision of the compilation of regulatory dossiers in accordance with national requirements.
- Gain regulatory authority approval and manage follow up post-approval activities.
- Provide regulatory support to clients and associate companies.
- Liaise with regulatory authorities as required.
- Provide format and content review/approval of labelling documents (SmPC, PIL and packaging information).
**Required profile**
- Degree in a scientific or (bio-)medical education (e.g. Pharmaceutical Sciences/Pharmacist, Bio-medical sciences, Drug Development, Lab technician or equivalent)
- Relevant work experience in a local BeNeLux Regulatory affairs role is a must have (minimum 3-5 years); this experience should include a proven understanding of the regulatory activities to be performed at local level for BeNeLux markets
- Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
- You’re open-minded, collaborative, team player, ready to adapt to the changing needs
- You’re curious about new techniques and tools, and eager to always keep learning
- You have good organizational and planning skills
- You are detail oriented
- Knowledge of pharmaceutical terminology is a plus
- You are fluent in Dutch or French and English
Dienstverband: Voltijds
Loon: Vanaf €4.000,00 per maand
Extralegale voordelen:
- Bedrijfscomputer
- Bedrijfswagen
- Een gsm voor professioneel gebruik
- Elektronische maaltijdcheques
- GSM-vergoeding
- Hospitalisatieverzekering
- Internetvergoeding
- Levensverzekering
- Tankkaart
- Thuiswerkopties
Rooster:
- Dagdienst
Soorten aanvullende vergoedingen:
- 13e maand
- Jaarlijkse bonus
- Vakantiegeld
Ervaring:
- regulatory affairs: 1 jaar (Vereist)
Werklocatie: Hybride telewerken in 9050 Gent
-
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...
-
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 Specialist
Il y a 7 mois
Gent, Belgique Jefferson Wells Temps pleinLocation: **Gent** **#23587** **Regulatory Affairs Specialist** Vast Contract - Regio Gent **#regulatory #affairs #specialist #food** Beschik je over een masterdiploma met een voorkeur voor een specialisatie in landbouw, voeding of chemie? Heb je min. 3 jaar ervaring in Regulatory Affairs? Ben je zelfstandig, zeer communicatief en computervaardig? Lees...
-
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...
-
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...
-
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...
-
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...
-
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...
-
Regulatory Affairs Specialist Crop Protection
Il y a 7 mois
Gent, Belgique Eastman Temps plein**The job**: We are looking for a Regulatory Affairs Specialist to support the global product stewardship and regulatory affairs Crop Protection team. In close collaboration with business, technology and product management, you give support in protecting the existing portfolio of products and actively engage in projects to extend our growth worldwide. This...
-
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...
-
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...
-
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 Assistant
il y a 1 jour
Gent, Belgique Asap.be Temps plein**Wat ga je doen?**: Support bieden bij het checken van labels voor compliance met de huidige regelgeving Ondersteunen van de regulatory afdeling door het verzamelen van product gegevens en die in te voeren in specifieke software. Creëren van overzichten voor het analyseren van deze gegevens. Update van Bartender labels, private labels, voorbedrukte zakken,...
-
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...
-
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...
-
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...
-
QAra Manager Healthcare
Il y a 7 mois
Gent, Belgique Robovision Temps plein**Who are we?** **Robovision** is a rapidly growing company at the forefront of AI development in Europe and beyond. We are active in several verticals, and for our healthcare vertical we’re developing state-of-the-art AI algorithms that will improve the outcomes and standard of care in hospitals. For this activity, we are looking for an exceptional...
-
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...
-
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...
-
Legal & Regulatory Specialist - Eneco Solar
Il y a 2 mois
Gent, Belgique Eneco Temps pleinGent Legal, Regulatory & Public Affairs Eneco Solar 3 - 5 jaar, 4 - 6 jaar Waar ga je werken?Eneco Belgium levert elektriciteit uit 100% hernieuwbare bronnen. Wat ons drijft? Een grote maatschappelijke betrokkenheid en verantwoordelijkheid. We willen een inspiratiebron zijn voor anderen door te laten zien dat een snelle transitie van fossiele naar duurzame...