Sr. Regulatory Affairs Specialist
Il y a 2 mois
For our Diabetes Care division, we are recruiting a Senior Regulatory Specialist for Benelux.
The Senior Regulatory Specialist is responsible for managing an efficient program to ensure that all regulatory activities for Abbott Diabetes Care products are achieved to an agreed schedule.
Role and Responsibilities:
- Formulate, develop and manage a program to enable all EMEAP registrations, when applicable, are completed efficiently and to an agreed schedule.
- Manage a roll out program for existing products and new launches.
- Work with the Regulatory Management team, Regulatory Affairs colleagues, and cross-functional team to develop and implement strategies that will ensure the timely introduction of products onto the international market.
- Manage the creation and development of Technical files and/or submission documentation for Abbott Diabetes Care devices in accordance with regulatory requirements, including MDR 2017/745 & IVDR 2017/746.
- Provide guidance to Regulatory colleagues in coordinating the preparation of regulatory submissions.
Your Profile:
- Educated to university degree level or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.
- Experience of working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), Medical Device Regulation 2017/745, and/or the IVD Directive (98/79/EC), IVDR 2017/746.
- Experience of working with local Regulatory requirements if applicable (Belgium, Luxemburg, The Netherlands)
- Ability to establish excellent working relationships with regional and global internal stakeholders and navigate complex matrix environments.
- Strong communication skills (verbal and written).
- English, French required. Dutch is a strong asset.
-
Sr. Regulatory Affairs Specialist
il y a 1 semaine
Wavre, Wallonie, Belgique Abbott Laboratories Temps pleinFor our Diabetes Care division, we are recruiting a Senior Regulatory Specialist for Benelux.The Senior Regulatory Specialist is responsible for managing an efficient program to ensure that all regulatory activities for Abbott Diabetes Care products are achieved to an agreed schedule.Role and Responsibilities: Formulate, develop and manage a program to...
-
Regulatory Affairs Specialist
il y a 1 semaine
Wavre, Wallonie, Belgique Haleon Temps pleinRegulatory Affairs Specialist: Wavre, Belgium; Amersfoort, Netherlands Legal and Compliance gsknchJob Description:Site Name: Belgium-Wavre, Netherlands - Amersfoort- Posted Date: Nov As a Regulatory Affairs Specialist in, you will play a critical role within a collaborative team of seven regulatory professionals based in the Netherlands and Belgium. Your...
-
Regulatory Affairs
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Belgium-WavrePosted Date: Mar 5 2024About the responsibilities: Drive the CMC strategy, coordinate the timely preparation and author, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory &...
-
Sr Manager, Global Regulatory Affairs
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: USA - Maryland - Rockville, Belgium-Wavre, Italy - Siena, Philadelphia Navy Yard, UK - United KingdomPosted Date: Mar 6 2023 Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK? If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore._ As Regulatory...
-
Regulatory Manager, Global Regulatory Affairs
Il y a 2 mois
Wavre, Belgique GSK Temps plein**Site Name**: Belgium-Wavre, GSK House, Italy - Siena **Posted Date**: Jan 18 2023 As Manager Global Regulatory Affairs, you will have global responsibility (for Regulatory Affairs) of given activities for Measles, Mumps, Rubella, and Varicella (MMR/V) Live Viral Vaccines lifecycle management within GSK Vaccines. **Key responsibilities**: - Provide...
-
Regulatory Manager, Global Regulatory Affairs
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Belgium-Wavre, GSK House, Italy - SienaPosted Date: Jan As Manager Global Regulatory Affairs, you will have global responsibility (for Regulatory Affairs) of given activities for Measles, Mumps, Rubella, and Varicella (MMR/V) Live Viral Vaccines lifecycle management within GSK Vaccines.Key responsibilities: Provide support to the Global Regulatory...
-
Gestionnaire Regulatory Affairs
il y a 1 semaine
Wavre, Wallonie, Belgique Laboratoire Huckert's International Temps pleinLe Laboratoire HUCKERT'S International, Laboratoire innovant et présent à l'international. Spécialiste de la bio-décontamination et de la désinfection de haut niveau en milieu médical, pharmaceutique et technologie de pointe recherche pour une entrée immédiate:**GESTIONNAIRE REGULATORY AFFAIRS (H-F)**Bilingue Français/ AnglaisLocalisation...
-
Regulatory Affairs Associate Director
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Belgium-Wavre, Baar Onyx, GSK House, Italy - SienaPosted Date: May The Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects.The purpose of this team is to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned...
-
Regulatory Affairs Associate Director
il y a 4 semaines
Wavre, Belgique GSK Temps plein**Site Name**: Belgium-Wavre, Baar Onyx, GSK House, Italy - Siena **Posted Date**: May 29 2024 The Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects. The purpose of this team is to ensure the development of appropriate global and/or regional regulatory strategy(s) and their...
-
Regulatory Affairs Associate Director
il y a 3 jours
Wavre, Belgique GSK Temps plein**Site Name**: Belgium-Wavre, Baar Onyx, GSK House, Italy - Siena **Posted Date**: May 29 2024 The Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects. The purpose of this team is to ensure the development of appropriate global and/or regional regulatory strategy(s) and their...
-
Regulatory Affairs
il y a 5 jours
Wavre, Belgique GSK Temps plein**Site Name**: Belgium-Wavre **Posted Date**: Mar 5 2024 **About the responsibilities**: - Drive the CMC strategy, coordinate the timely preparation and author, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the...
-
Senior Manager Regulatory Affairs, Grl Delegate
il y a 3 semaines
Wavre, Belgique GSK Temps plein**Site Name**: Belgium-Wavre **Posted Date**: Mar 17 2023 As a Senior Manager Regulatory Affairs, GRL Delegate, you will have global responsibility (for Regulatory Affairs) for the development and lifecycle activities related to pneumococcal vaccines**.** This role will provide YOU the opportunity to lead key activities to progress YOUR career, these...
-
Gestionnaire Regulatory Affairs
il y a 3 semaines
Wavre, Belgique Laboratoire Huckert’s International Temps pleinLe Laboratoire HUCKERT’S International, Laboratoire innovant et présent à l’international. Spécialiste de la bio-décontamination et de la désinfection de haut niveau en milieu médical, pharmaceutique et technologie de pointe recherche pour une entrée immédiate: **GESTIONNAIRE REGULATORY AFFAIRS (H-F)** Bilingue Français/ Anglais Localisation...
-
Senior Manager Regulatory Affairs, Grl Delegate
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: Belgium-WavrePosted Date: Mar As a Senior Manager Regulatory Affairs, GRL Delegate, you will have global responsibility (for Regulatory Affairs) for the development and lifecycle activities related to pneumococcal vaccines.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some...
-
Internship : Scientist Global Regulatory Affairs
il y a 3 semaines
Wavre, Belgique GSK Temps plein**International environment with our Internship Programme**: **Education required**: University level (MSc or Engineer) **Other requirements**:We are looking for students with the following skills: - Good interpersonal communication skills - You are honest and transparent - Your internship will last for at least three (3) months **Language requirement**:...
-
Regulatory Affairs Associate Director
il y a 4 semaines
Wavre, Belgique 1849 GlaxoSmithKline Biologicals S.A. Temps pleinThe Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects. The purpose of this team is to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s), across all stages of the product life cycle and consistent with...
-
Associate Director, Regulatory Affairs Vaccines Therapeutic Group
il y a 4 semaines
Wavre, Belgique 1849 GlaxoSmithKline Biologicals S.A. Temps pleinThe Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects. The purpose of this team is to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s), across all stages of the product life cycle and consistent with...
-
Regulatory Affairs Associate Director
il y a 3 semaines
Wavre, Belgique 1849 GlaxoSmithKline Biologicals S.A. Temps pleinThe Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects. The purpose of this team is to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s), across all stages of the product life cycle and consistent with...
-
Senior Director, Global Regulatory Affairs, Vaccines
Il y a 2 mois
Wavre, Belgique GSK Temps plein**Site Name**: USA - Maryland - Rockville, Belgium-Wavre, Durham Blackwell Street, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence **Posted Date**: Jul 26 2023 Are you looking for a highly visible global regulatory leadership role where you can build advocacy and accelerate regulatory compliance on an international scale? If so, this...
-
Senior Director, Global Regulatory Affairs, Vaccines
il y a 1 semaine
Wavre, Wallonie, Belgique GSK Temps pleinSite Name: USA - Maryland - Rockville, Belgium-Wavre, Durham Blackwell Street, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: Jul Are you looking for a highly visible global regulatory leadership role where you can build advocacy and accelerate regulatory compliance on an international scale? If so, this Senior Director role...