Regulatory Affairs & Market Access Manager : Parallel Import
Did you know that there are currently dozens of molecules available in various EU member states that can't be found in Belgium except through maybe one or two manufacturers? This has caused a big discrepancy in availability of some pharmaceuticals and has also caused situations where monopoly holders are unmotivated to produce better quality or cheaper products. With no incentive for competition, the end-consumer pays the high price!
No longer will this be the case though!
My client, specialised in parallel imports, is fighting against these unjust situations! Legally importing pharmaceuticals from other EU member states, they offer both consumers and pharmacists the possibility to choose between molecules rather than being forced to take a specific one.
Regulatory Affairs professionals have often been described as the guardian angels of the industry, and it has certainly never been truer than with this company.
By applying for this position, you are making the conscious choice of putting the consumer & community first.
* Manage the RA team, develop the Regulatory Strategy, report the KPIs of the team and identify continuous improvement opportunities
* Represent the RA department in cross-departmental meetings and be responsible for management and followup of RA related queries
* Help with due diligence and integration of new product developments/new product introductions
* Responsible for the preparation of the dossiers, submissions of license requests, renewals and variations towards the local health authorities.
* Responsible for maintenance of the RA database, monitoring start/stop commercialisation, communicating product availability or shortages with the FAMHP, overall full life-cycle of the product.
* Give final approval for artwork or comment where needed.
* Keep a going awareness of new and developing regulations
* Responsible for all aspects related to price and reimbursement.
* Communicate/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.
* Be the primary contact person with the RIZIV regarding the follow-up of the process and adjustment of the price positioning (trimestrial), follow-up and interpret saving measurements.
Management : you will be in charge of quite a large team of 4-6 people (consultant dependant)
- Scientific background: ideally a background in pharmacy, biochemistry, engineering, etc...
- At least 7-8 years of relevant experience in the pharmaceutical industry
- Good knowledge of the relevant European regulations (Belgium primarily) for manufacturing of pharmaceutical products
- Good knowledge of manufacturing process for injectables and tablets
- Knowledge of and experience in FDA regulations is an asset though not required
- Dutch & English speaker. Some flexibility for an English only speaker provided you have excellent experience
If you are interested in this challenge, please contact me through the follow methods:
- +32 28 91 98 99 extension 3147
- Michael van Hooft