Regulatory Affairs Manager
il y a 3 semaines
About EG
EG is a Purpose driven company: at the core of everything we do, we aim to Care for People´s Health as a Trusted Partner.
EG is also 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.
Most of our medicines and food supplements are produced in Belgium. We currently have 170 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 biosimilarsOur 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.
We are part of the STADA Group and share the values Integrity, Agility, Entrepreneurship and One Stada.
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.
Regulatory Affairs Manager (f/m/x)
Brussels | BE | Full Time | Permanent
About the Pharmaceutical Affairs Department
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 Manager (RAM) is responsible for the coordination of the lifecycle management of the medicines and non-medicines (e.g. food supplements and medical devices) in Belgium and Luxembourg.
The RAM will collaborate with internal stakeholders (including Supply Chain, Sales and Marketing) 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.
This role leads a team of 4 Officers and reports to the Pharmaceutical Affairs Director.
The RAM participates in the Quality Management Meetings, Pharmaceutical Affairs Team Meetings, Regulatory Affairs Meetings and other ad hoc meetings (both internal and external).
How you can make an impact
Follow up of new registration procedures until launch
The RAM organizes and coordinates RA activities to ensure that the registration of new medicines and the maintenance of existing registrations are carried out in the most optimal way.
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 sales for our products within the legislative framework. This includes the coordination of the preparation, submission and follow-up of variations, renewals and notification dossiers, managing communications with regulatory authorities and the coordination of initiating, reviewing and approving changes to packaging materials (e.g. artworks).
Legislation, procedures and work instructions
Acquiring and maintaining knowledge regarding national and European legislation, guidelines and the application of that in procedures and work instructions within the framework of the general EG quality system. The RAM is responsible for keeping the team informed of changes.
Scientific support
Providing scientific support and 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, Marketing, Finance, …
Leadership
Leading RA team members to have an efficient department that optimally executes objectives and develop them to their full potential.
What we are looking for
Motivated, Energetic and Passionate (MEP) You act in line with our values: Integrity, Entrepreneurship, Agility and One Stada. Master degree in life sciences (e.g. Pharmaceutical Sciences/Pharmacist, Bio-medical sciences, Drug Development or equivalent) Relevant work experience: minimum of three years of experience in regulatory affairs You're open-minded, collaborative, team player, ready to adapt to the changing needs. Effective oral and written communication skills Experience in People & Project Management is an asset Fluent in Dutch, French, English We hire for attitudeHow we care for you
Your efforts will be rewarded with an attractive and competitive salary. On top of this you will receive a full package of fringe benefits such as meal and eco vouchers, group insurance, ambulatory care and hospitalization coverage, laptop & smartphone So, you go through life with less worries We offer a company car including a fuel card. Do you prefer to get some fresh air every morning and evening? Great Because bicycle leasing is also possible as part of our cafeteria plan. You also get to enjoy a very nice work-life balance with 32 vacation days and a flexible work schedule. Working from home for two days a week is also possible. Finally, you can count on a big smile from your new colleagues every day We all work towards one common goal: Caring for People's Health as a Trusted Partner, with the same Motivation, Energy and Passion across all departments. You will have regular the possibility to connect with all our Belgian colleagues during our ATN (All Together Now) events.More information about EG and what is to work for us? Visit
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