Looking for a talented Regulatory Affairs / Market Access Manager to help our client proactively managing the lifecycle of the medicinal products.
The Regulatory Affairs / Market Access Manager undertakes full responsibility of the following:
- Lead the RA team, develops the Regulatory Communication Strategy, report the Key Performance Indicators of the team and identify continuous improvement opportunities
- Represents RA in cross-departmental meetings and is responsible for management and follow-up of RA related priorities and questions
- Helps with due diligence and integration of new product developments/new product introductions
- You are responsible for the preparation of the dossier, submission of license requests, renewals and variations towards the local health authorities
- You are responsible for the maintenance of the RA database, monitoring start / stop commercialization, communicating product availability or shortages with the FAGG, overall full life-cycle of the product.
- You give final approval for artwork or comment where needed
- Keeps a going awareness of new and developing regulations in the respective field of expertise
- You are responsible for all aspects related to price and reimbursement.
- You communicate and agree prices with the ministry of economic affairs and price requests with the ministry of social affairs (RIZIV) depending on the registration status and pricing structure
- You are the primary contact person with the RIZIV regarding the follow-up of the process and adjustment of the price positioning (trimestrial check), follow-up and interpret saving measurements
- Responsible for people management, coaching the RA team and look after the further development of the expertise within the team by education and training
The Regulatory Affairs / Market Access Manager will act according to the companies’ mission, vision and strategy.
- The successful candidate must have proven skills in Regulatory Affairs
- Have at least 8 years relevant experience in RA in the pharmaceutical industry amongst which Market Access Area (regulatory, product pricing, listing, reimbursement and/or HEs).
- You will be responsible for all areas within RA and Market Access.
- You will report directly to the companies’ Group QA Director and will be based in Brussels.
Interested in this job?
Send us your CV and motivation to: firstname.lastname@example.org