For one of our clients, in the region of West-Brussels, we are looking for a Regulatory Affairs Manager:
- Do you have a Master in Pharmaceutical Sciences
- Are you trilingual (English/French/Dutch)?
- And are you looking for a broad opportunity (RA/ PV/ Market Access…)?
Then look no further, this is the opportunity you have been looking for!
For this opportunity, we are looking either for a long-term commitment or a freelancer who could bridge the period while searching for a permanent solution.
- Translation of local product information
- Review and approval packaging materials
- Contact person with local authorities for specific issues
- Follow up of local or regional legislation
- Review of promotional /educational materials
- SOP management
- Follow-up good distribution practices samples Belux
- Performing self-inspections/auditing
- Acting as local recall coordinator
- Local contact person for PV: Primary contact for follow-up questions local ICSR
- Review of drug safety literature
- Execute local risk management activities
- Developing pricing and reimbursement strategy for GR products BNL in consultation with medical/marketing /sales
- Contacting KOLs and authorities to support the strategies
- Elaborate and defend the reimbursement and pricing applications
- Lobbying-in collaboration with GM
- Analyzing current BNL pricing and reimbursement environment and evaluating consequences on GR portfolio in Benelux
- Trilingual (ENG/NL/FR)
- Min. 5 years’ experience in pharmaceutical industry (RA/PV/ Market Acces/Quality)
- Scientific Master (Pharmaceutical Sciences)
- Strong knowledge of current health care procedures for pricing, reimbursement, regulations, and ethics
- Passionate for in depth and detailed work
- Strong scientific attitude with personal organizational skills (priority setting)
- Ability to multi-task in cross-functional teams
- Ability to think solution oriented
+32 15 21 11 04