Regulatory Affairs Officer - Brussels, België - STADA Arzneimittel AG

STADA Arzneimittel AG

Geverifieerd bedrijf

Brussels, België

5 dagen geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

About EG

EG is the largest pharmaceutical company in Belgium.
With an offering for just about every therapeutic area, we are the market leader in generic medicines and the biggest OTC company in Belgian pharmacies.
We still produce many of our medicines and food supplements in Belgium.

We currently have 180 employees and continue to invest in:

The development of generic medicines to keep qualitative healthcare affordable
Scientifically proven food supplements and medical devices that you can buy without a prescription in your pharmacy
The development of highly specialized medicines and biosimilars
Our culture is characterized by the strong commitment of our employees.

Internally, we are called "MEP's":
-
Motivation

Energy

Passion are therefore qualities that we look for in every potential new employee to help strengthen our culture.- Do you have a strong MEP level? Are you entrepreneurial and would you like to work for the largest and fast-growing pharmaceutical company in Belgium? Then EG might be the perfect employer for you.
About the Department Pharmaceutical Affairs

Pharmaceutical Affairs (PA) Department consists of Regulatory Affairs, Quality Assurance, Medical Affairs and Pharmacovigilance. The department ensures that our products are produced and delivered to customers according to the highest quality and safety standards and complying with the local and EU regulatory requirements.
About your role
The Regulatory Affairs Officer (RAO) is responsible for managing the lifecycle of the medicines from the preparation of the registration dossier, including the followup and finalization of new registrations, the preparation to market access, compilation, submission, and followup of variation dossiers in Belgium and Luxembourg.
Also managing the lifecycle of nonmedicines (e.g. food supplements and medical devices) by preparing, compiling, submitting and following up the notification files in Belgium and Luxembourg.
The RAO will provide administrative assistance to internal stakeholders (including Supply Chain Department, Sales and Marketing Department) and external customers (including regulatory authorities and professionals in the medicalpharmaceutical world) to ensure a smooth launch and continuity of the products on the market and good sales.
This role is part of a team of 4 Officers and reports to the Regulatory Affairs Manager.
Responsibilities
Follow up of new registration procedures until launch
The RA Officer is responsible for submitting, following up and finalizing registration procedures to obtain a marketing authorization as quickly as possible to be able to commercialize the product in Belgium and Luxembourg within the set time frame.
Managing and maintaining registered corporate and noncorporate procedures
Managing existing corporate (DCP, MRP, CP) and noncorporate (NAT) registrations in Belgium and Luxembourg to guarantee the continuity of the supply of the products within the legislative framework. This includes the preparation, submission and followup of variations, renewals and notification dossiers. Also initiating, reviewing and approving changes to packaging materials (e.g. artworks).
Keeping databases uptodate
Taking care of the correct management of various internal and external databases to ensure permanent access to necessary information regarding the products.
Legislation, procedures and work instructions
Scientific support
Providing scientific support with regard to answering pharmacotechnological questions from patients, doctors, pharmacists and/or hospitals.
Work closely together with colleagues from all other departments within EG: Supply Chain, Business Development, Sales and Marketing, Finance,
Required profile
Degree of Bachelor, Higher education or Master in a scientific or (bio)medical education (e.g. Pharmaceutical Sciences/Pharmacist, Biomedical sciences, Drug Development or equivalent)
Relevant work experience: 04 years
You're openminded, collaborative, team player, ready to adapt to the changing needs
You're curious about new techniques and tools, and eager to always keep learning
You have good organizational and planning skills
Knowledge of pharmaceutical terminology is a plus
You are fluent in Dutch, French and English
We hire for attitude
We expect from our employees to be Motivated, Energetic and Passioned (MEP) by their job
You act in line with our values: Integrity, Entrepreneurship, Agility and One EG.