What we offer

Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Job Description

Keyrus Life Science is looking for a Support in Regulatory Affairs to join our consulting team for a client project based in Brussels. 

The collaboration takes place with other RA team members, colleagues of the other business units. The contractor supports Senior Regulatory Affairs Managers (RAMs) with specific RA matters between the company and the Dutch, Belgian and Luxemburg authorities.

1. General RA tasks

2. Regulatory Procedures

The contractor supports life cycle management of Veterinary Medicinal Products (VMPs). This concerns the following tasks:

• Supporting the RAM in case of RA product procedures.
• Communicating about RA procedures with 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 and GRA departments, as well as contact with the national authorities (aCBG-BD and FAGG).

3. 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 and the GRA Operations Labeling (GRAOP Labeling) department.

4. 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).

5. 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 and Quality Assurance (QA) departments, as well as contact with the national authorities.
 
6. Pharmacovigilance

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 and the QA and PV departments, as well as contact with the national authorities.

7. Finance

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 and GRA, as well as contact with the national authorities (aCBG-BD and FAGG).

Profile

• 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.
• Excellent speaking and writing capabilities of the Dutch, French and English language. Good writing capabilities of the German language.
• Stress resistant and firm.
• Result driven.
• Compliance and quality driven.
• An accurate and systematical way of working.
• Pragmatic and flexible.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skilfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.