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Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.
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Regulatory Affairs Specialist
The Regulatory Affairs Specialist has as primary task to take care of supporting Regulatory Affairs (RA) activities of the RA Unit.
This means supporting life cycle management of product registrations of the Benelux activities of our global client.
In addition, in this role you have executive and controlling tasks in activities that are directly or indirectly related to the registration of products.
You maintain contact with stakeholders inside and outside the company, defend the interests of the company and consider the requirements of the law and legislation and the business principles of the company.
At the moment this role is 2 days in the office, 3 days remote.
In this role you collaborate with other RA team members, colleagues from local business units and colleagues from global teams.
You support the Senior Regulatory Affairs Managers (RAMs) with specific RA matters between the global company and the Dutch, Belgian and Luxemburg authorities. In this role you are a contact point for Global RA managers and for the persons working at the agentschap College ter Beoordeling van Geneesmiddelen – Bureau Diergeneesmiddelen (aCBG-BD), the Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) and Sciensano.
Scope of work:
- General RA tasks
- Acting as a source of information for internal employees regarding RA information.
- Participating in general RA meetings to be aware of RA activities on the one hand and to bring forward relevant RA topics on the other hand.
- Taking care of the general RA inbox in Outlook.
- Taking care of the general PV inbox in Outlook.
- Selecting relevant information from the Staatscourant in the Netherlands.
- Scanning and sending documents.
- Archiving of documents (on paper and/or electronically)
- Digitalizing of paper dossiers of products.
- Regulatory Procedures:
In this role you support life cycle management of Veterinary Medicinal Products (VMPs) of our client. This concerns the following tasks:
- Supporting the RAM in case of RA product procedures.
- Communicating about RA procedures with Global RA teams and national authorities.
- Controlling excel files with information on RA procedures or products.
- Entering and checking of RA information on products.
- Translating product information, i.e. Summary of Product Characteristics (SPC), leaflets, labels, boxes, etc.
These tasks involve collaboration with the relevant RAM of our client and the Global RA department, as well as contact with national authorities (aCBG-BD and FAGG).
- Packaging tasks:
In this role you support the RAMs in keeping the leaflets and packaging materials of certain groups of products up to date. This involves working with the company’s packaging database ARTIS and involves the following tasks:
- Starting new packaging items (package leaflet, label and box) in ARTIS.
- Changing existing packaging items and starting the ARTIS process flow.
- Checking of correct packaging after asking product samples from the warehouse.
- Controlling excel files with information on packaging items.
These tasks involve collaboration with the relevant RAM of our client and the Global RA Operations Labeling (GRAOP Labeling) department.
- Repertorium and E-compendium
In this role you are responsible for keeping up-to-date the RA texts of VMPs in e.g. the Repertorium (the Netherlands) and the E-compendium (Belgium). This involves the following tasks:
- Checking the VMP texts in the Repertorium and the E-compendium.
- Starting new VMP texts in the Repertorium and the E-compendium.
- Changing VMP texts in the Repertorium and the E-compendium.
These tasks involve collaboration with the relevant RAM and a Commercial Demand Planner (CDP) of our client, as well as contact with the Fidin and Pharma.be
- Batch application and batch release:
In this role you are responsible for applying for batch releases of vaccines at the national authorities and supports in the release of product batches in the Benelux market. This involves the following tasks:
- Filling in and submitting the batch release application to the national authority.
- Communicating national authority batch approvals with the CDPs.
- Controlling excel files with information on batch applications and releases.
These tasks involve collaboration with the relevant RAM and CDP of our client and Quality Assurance (QA) departments of our client’s parent branch, as well as contact with national authorities (aCBG-BD and Sciensano).
In this role you are responsible for entering and following Product Quality Complaints (PQCs) and supports the Sr. Pharmacovigilance Managers (PVM) with Adverse Events (AEs). This involves the following tasks:
- Entering and following PQCs.
- Controlling excel files with information on PQCs and AEs.
These tasks involve collaboration with a PVM of our client and the QA and PV departments of our client’s parent branch, as well as contact with national authorities (aCBG-BD and FAGG).
In this role you support the RA Unit by taking care of invoices from national authorities for RA topics. This involves the following tasks:
- Checking and approving RA invoices from national authorities (aCBG-BD and FAGG) on RA procedures, annual fees, etc. in SAP
- Checking and approving RA invoices from Sciensano on batch applications in Belgium in SAP.
- Checking and approving RA invoices on Antibiotic and Packaging tax in Belgium.
- Controlling excel files with information on RA procedures and corresponding invoices.
- Communicating with GRA on invoices paid on behalf of Intervet International B.V.
These tasks involve collaboration with the RAMs and Associate Directors of local and global RA teams, as well as contact with national authorities (aCBG-BD and FAGG).
Who are you?
- Secondary or Higher Education in the Life Science field (secretaries, agricultural, laboratorial, etc.)
- Knowledge and experience in the area of RA, preferably of veterinary medicines
- Stress resistant and firm
- Result driven
- Compliance and quality driven
- An accurate and systematical way of working
- Pragmatic and flexible
- Excellent speaking and writing capabilities of the Dutch, French and English language
- Good writing capabilities of the German language
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
Are you interested? Apply now with your cv!