Hobson Prior are looking for a Global Regulatory Leader - Medical Devices to strengthen the Global Regulatory Affairs department at a leading biopharmaceutical company on a permanent basis either in the USA or UK.

Job Responsibilities:

• Act as the Regulatory point of contact on the assigned Mission/PST with senior management providing the agreed global regulatory strategic recommendations and risk assessment for key projects.
• Partaking and contributing to PVU 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.
• Being responsible for the timely development and implementation of the global regulatory strategy and plans designed to meet the needs of the business and patients for assigned Missions and/or projects.
• Chairing the global Regulatory Strategic Team meeting 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, on behalf of the Mission/PST, discussions around Practice resource needs and Mission regulatory budget to deliver Mission/PST and agreed upon GRA objectives.

Requirements:

• You will have several years' experience in pharmaceutical regulatory affairs.
• Knowledge of scientific foundation, enough to understand all aspects of regulatory issues in an authoritative way and discuss with technical experts.
• An understanding of global regulatory procedures and legislation for overall drug development, regional regulatory experience, clinical trial submission, product registration, line extension and license maintenance.
• Global and integrated cross-functional view into pharmaceutical project management and drug development/approval and commercialization.
• Good track record of contributing to delivering regulatory approvals.
• Direct experience in interacting with and negotiating with health authorities, including milestone meetings.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.