Regulatory Affairs Officer

Job Description

Company: EG NV/SA

Department: Pharmaceutical Affairs

Job Location (Long):

Brussels|Belgium

Country/Region: Belgium

Job Level: Professionals

Information at a Glance

At STADA we pursue our purpose \"Caring for people's health as a trusted partner\" worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

The pharmaceutical company EG is a Belgian company and leader of generic medicines in Belgium. Today, the company counts 190 collaborators. EG is part of STADA Group and consists of 3 divisions: EG Generics, Consumer Care & Specialty Care. With over 30 years of experience, EG is the indisputable market leader of generic medicines in Belgium. The EG Generics portfolio contains almost 700 medicines (mostly prescription medicines) destined for the treatment of health problems in almost every therapeutic domain. The EG team also offers continuous practical support to doctors and specialists for a responsible and affordable patient care. EG Consumer Care creates innovative brands of nutritional supplements, medical aids and medicines that are available in pharmacies without prescription (OTC). We emphasize 'evidence-based nutraceuticals': nutritional supplements that are scientifically tested and who help you sustain your health. EG Specialty Care also offers very specialized prescription medicines – mainly to hospitals and psychiatric institutions. We are also working on expanding the product line with, among others, biosimilars. To strengthen our team, we're looking for a:

Regulatory Affairs Officer

Brussels | Belgium (BE) | Full-time | Permanent

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\": M otivation – E nergy – P assion 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 follow-up and finalization of new registrations, the preparation to market access, compilation, submission, and follow-up of variation dossiers in Belgium and Luxembourg.

Also managing the lifecycle of non-medicines (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 medical-pharmaceutical 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 non-corporate procedures

Managing existing corporate (DCP, MRP, CP) and non-corporate (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 follow-up of variations, renewals and notification dossiers. Also initiating, reviewing and approving changes to packaging materials (e.g. artworks).

Keeping databases up-to-date

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

Acquiring and maintaining knowledge with regard to national and European legislation, guidelines and the application thereof in procedures and work instructions within the framework of the general EG quality system

Scientific support

Providing scientific support with regard to answering pharmaco-technological 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, Bio-medical sciences, Drug Development or equivalent)
• Relevant work experience: 0-4 years
• You're open-minded, 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

Do you have the Motivation, Energy and Passion it takes? Then this job might be for you. Apply now