Description
We have an exciting opportunity for a Regulatory Affairs Director based in the UK or Belgium office.The role has been created to due increase in workload and ambitious plans to manage products launches globally.
This position is responsible for providing global regulatory leadership to assigned projects by developing and executing regulatory strategies, budget, and outlining plans for achieving objectives.
Responsibilities:
* Designing and implementing global regulatory strategic recommendation and risk assessment for key projects within assigned area
* Identifying any potential risks along with possible contingencies to ensure the most appropriate submission timing leading to the earliest and most optimal approval of key deliverables.
* Accountable for oversight of all global health authority interactions for assigned projects, ensuring alignment of the regulatory strategies, and technical support to teams in rehearsals ensuring global alignment of key messages
* Participate and contribute to global strategic initiatives and tactical plans related to gathering and analyses of customer needs
* Chair the global Regulatory Strategic Team meetings to ensure prioritised objectives that focus on the critical activities successfully delivered within required time and expectations
* Lead and coordinate discussions around Practice resource needs and Mission regulatory budget to deliver projects within agreed objectives
* Assist in regulatory initiatives (internal or external) leading to process improvement and development of specialized expertise as needed
* Designing and implementing agreed global regulatory strategic recommendations and risk assessment for key projects for assigned projects
Requirements:
* Experience delivering global regulatory affairs projects within agreed timescales and budgets
* Robust knowledge of global regulations and legislation for pre and post-approval submissions, product registrations, line extensions, and licences maintenance
* Experience in leading successful teams
* Direct experience interacting with health authorities
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.