Description
Global pharmaceutical company, based in Belgium, Brussels has a new opportunity for experienced Regulatory Affairs Manager to take on responsibility for tasks related to development of successful strategies for product approval globally. This role has been created due to very busy product pipeline and plans to product launch on new markets.Responsibilities:
* providing support and expertise to global regulatory strategic recommendations and risk assessment for key projects.
* developing and implementing the global regulatory strategy and plans
* Participating and contributing to the global strategic initiatives and tactical plans related to the gathering and analyses of customer insights in the field and the consequential design/adaptation of Mission/PST business strategies.
* Chairing the global Regulatory Strategic Team meetings for the Mission and/or product, to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality
* Leading and coordinating discussions around Practice resource needs and Mission regulatory budget in order to deliver objectives
Requirements:
* Strong experience in pharmaceutical regulatory affairs function leading and delivering successful product approvals for biological therapies
* Knowledge of global regulatory procedures and legislation for overall drug development, regional regulatory experience such as product registration, line extension, license maintenance and marketing authorisation
* Direct experience in interacting with and negotiating with health authorities, including milestone meetings.
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.