This opportunity is open for candidates with experience in Regulatory Affairs within the pharma industry and with a good knowledge of Dutch, French and English.
This is an hybrid working opportunity (min 2 days/week on-site is required)
The RA Consultant is responsible to obtain, maintain, update and implement the authorizations for (para)pharmaceutical products to be marketed in Belgium and Luxembourg as well as to commercialize the existing products in accordance with the regulations (including answers to pharmaceutical questions and publicity in order to contribute to the realization of the mission.
Observation of the market / working environment
- Establish and develop a network of informal contacts with colleagues from the Belgian Science Team (Pharmacovigilance, Quality, Medical Information).
- Regularly consult with management regarding their objectives and strategies that impact Regulatory Affairs regarding the products in the respective portfolios.
- To inform oneself about regulatory developments. To continuously inform oneself about the European medical and pharmaceutical legislation regarding regulatory matters.
- Building a network of informal contacts with the local Health Authority and local/EU Trade Associations.
The concrete implementation of the strategy/activity plan
- As expert and registration responsible for his/her products, prepare, compile, manage, follow up and implement the registration files for his/her (para)pharmaceutical products in order to obtain Marketing Autorisation.
- Submission and follow-up of registration dossiers of products covered by the application of the mutual recognition procedure/decentralized procedure and the national procedure
- Responsible for maintaining the registration of existing products
- Follow closely the additional questions that the Health Authority might ask in connection with the filing, management and follow-up,as well as the answers formulated to them
- To continuously update the specifications of existing registered products, both at the pharmaceutical level (analytical variations), and at the pharmaco-clinical level (alignment with Core Safety Information), according to information obtained by the group and/or from the medico/pharmaceutical environment;
- Ensure that the internal databases for the products in its portfolio are constantly up to date, compendia and repertories, filing, ...
- Oversee the creation of packaging in accordance with regulations and internal guidelines on the subject through VistaLink.
As an expert in regulatory affairs, ensure that regulations related to the drug are applied and complied with both during the development and during the life of the drug:
- On a continuous basis, implement national and european regulations, directives and circulars;
- Participate in the preparation of Standard Operating Procedures;
- Ensure the compliance of the promotional material with the product specifications and regulations in force regarding medical information and publicity.
- You have a master's degree in a scientific field such as pharmaceutical sciences (pharmacist), drug development, biomedical sciences, bioengineering, (bio)chemistry or similar
- You have previous RA experience within a pharmaceutical industry environment
- You are familiar with the different stages of drug development and production in a pharmaceutical company.
- You have experience with local authorities in Belgium & Luxembourg
- You have a good knowledge of the relevant national, European and international legislation, procedural regulations and technical rules for products with different legal statuses.
- You are fluent in Dutch, French and English.
- You can work independently and in an organized manner. You have an excellent sense of priorities.
- You work very accurately.
- You are flexible and you can adapt to changing circumstances/needs.
- You stay informed of developments in the field.
- You have a good knowledge of Word, Excel and Outlook
- Existing right to work in Europe is required
- Long term opportunity
- A balanced salary package based on your capabilities and experience
- Hybrid working opportunity (min. 2 days/week on site)
- Full-time position
Vacancy number: 20898