About this job
- Market: Life Sciences & Health Care
- Branche: Pharmaceutical
- Area of expertise: Regulatory
- Location: HEIST-OP-DEN-BERG
What is required?
- Hours per week: 40
- Education level: Academic Master
- Closing date: Saturday, July 30, 2022
About this role: Support in Regulatory Affairs - Animal Health
Brunel is an international company with a long history of success in project sourcing. Our unique reputation is built on our strength and stability, but above all on our consultants. It's they who make the difference. Their motivation, passion and energy form the basis of our success formula.
Do you want to be part of our team?
For our client, active in the pharmaceutical sector, we are currently looking for a Support in Regulatory Affairs to strengthen the team. Does this sound like something for you?
First things first: What can you expect on the job?
• 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:
The contractor supports life cycle management of Veterinary Medicinal Products (VMPs) of MSD AH. This concerns the following tasks:
- Supporting the RAM in case of RA product procedures.
- Communicating about RA procedures with MSD AH Global RA (GRA) and the 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 MSD AH Benelux and the MSD AH GRA department, as well as contact with the national authorities (aCBG-BD and FAGG).
• Packaging tasks:
The contractor supports 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 MSD AH Benelux and the MSD AH GRA Operations Labeling (GRAOP Labeling) department.
• Repertorium and E-compendium
The contractor is 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 MSD AH Benelux, as well as contact with the Fidin and Pharma.be
• Batch application and batch release:
The contractor is 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 MSD AH Benelux and Quality Assurance (QA) departments of MSD AH Global, as well as contact with the national authorities (aCBG-BD and Sciensano).
The contractor is 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 MSD AH Benelux and the QA and PV departments of MSD AH Global, as well as contact with the national authorities (aCBG-BD and FAGG).
The contractor supports 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 the 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 MSD AH Benelux and MSD AH GRA, as well as contact with the national authorities (aCBG-BD and FAGG).
What you need to bring:
What do we expect from 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
Boosting your career is what we get up for every day. At Brunel we go the extra mile for you. As an employer Brunel strives for long-term partnerships with its employees. Do you?
If you get started within our Life Sciences specialism you will end up in a close community of Quality Officers, Validation Engineers, R&D Scientists, Process Engineers, etc. Moreover, you will be succeeded by not one, but two Brunellers. Your Business Developer is one of them, but on top of that there is also a Talent Business Partner who remains your permanent contact throughout your career. This person is your listening ear and, together with you, looks for the best experience to further develop your talent.
Furthermore, you can count on an open-ended contract with an attractive salary package, combined with various fringe benefits. On top of that, you get 12 extra days off to take some well-deserved rest.
Ready for that extra step? Apply today.
Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Tiffany Resseler is happy to clarify anything about this vacancy. When reaching out, use this number:
Brunel Belgium Mechelen