Regulatory Affairs Manager

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!

Job Description 

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. 

Responsibilities 

Regulatory affairs

  • 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

Quality assurance

  • SOP management
  • Follow-up good distribution practices samples Belux
  • Performing self-inspections/auditing
  • Acting as local recall coordinator

Pharmacovigilance

  • Local contact person for PV: Primary contact for follow-up questions local ICSR
  • Review of drug safety literature
  • Execute local risk management activities

Market access

  • 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
Profile 
  • 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
Contact Information 

Ellie Depape

+32 15 21 11 04

Ellie.depape@valesta.com

Application form : Regulatory Affairs Manager

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