Support in Regulatory Affairs Nl/en - Brussels, België - Keyrus Life Science Belgium

Keyrus Life Science Belgium

Geverifieerd bedrijf

Brussels, België

3 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

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.

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

The Support in Regulatory Affairs has as primary task to
take care of supporting Regulatory Affairs (RA) activities of the RA Unit.

Collaboration takes place with other RA team members, colleagues of the other business units and colleagues from the global department of Animal Health.

The contractor
supports Senior Regulatory Affairs Managers (RAMs) with specific RA matters
between Global RA and the Dutch, Belgian and Luxemburg authorities.

General RA tasks
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.
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).

This concerns the following tasks:

Supporting the RAM in case of RA product procedures.
Controlling excel files with information on RA procedures or products.
Entering and checking of RA information on products on request of the RAM.

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 and involves the following tasks:

Starting new packaging items (package leaflet, label and box) on request of the RAM.
Changing existing packaging items on request of the RAM.
Reviewing if the packaging is correct.
Controlling excel files with information on packaging items.
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 Ecompendium on request of the RAM.
Uploading new VMP texts in the Repertorium and the Ecompendium on request of the RAM.
Changing VMP texts in the Repertorium and the Ecompendium on request of the RAM.

These tasks are administrative tasks and involve collaboration with the relevant RAM and Quality Assurance (QA) departments, as well as contact with the national authorities (aCBG-BD and Sciensano).

Pharmacovigilance:
The contractor is responsible for
entering and following Product Quality Complaints (PQCs) and supports the Sr. Pharmacovigilance Managers (PVM) with Adverse Events (AEs).

Finance:
The contractor supports the RA Unit by
taking care of invoices from national authorities for RA topics.

These tasks involve collaboration with the RAMs and Associate Directors Benelux and GRA, as well as contact with the national authorities (aCBG-BD and FAGG).

Profile

S
econdary or Higher Education in the Life Science field (secretaries, agricultural, laboratorial, etc.).

-
2-3 years of experience in the area of RA, preferably of veterinary medicines.

Excellent
speaking and writing capabilities of the Dutch and English language.
Notions of French and German are a plus.
Stress resistant and firm.
Result driven.
Compliance and quality driven.
An accurate and systematic 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