Regulatory Affairs/ Market Access Manager

13 May 2020
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Description

Looking for a talented Regulatory Affairs / Market Access Manager to help our client proactively managing the lifecycle of the medicinal products.

Function

The Regulatory Affairs / Market Access Manager undertakes full responsibility of the following:

Regulatory Affairs

  • 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

Market Access

  • 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

People Management

  • 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.

Profile

Qualification/skills:

  • 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).

Offer

  • 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: staffing@triumclinicalconsulting.com