HEAD OF REGULATORY AFFAIRS

Global Biopharmaceutical Organisation

Reference 68562-RA

Our client, a leading biopharmaceutical research, development and manufacturing organisation, is seeking a Regulatory Affairs Site Lead to join its manufacturing operation in Ireland.  This is an opportunity to join at a particularly exciting time in the company’s development and to truly shape its RA thinking, both in Europe and internationally.  The Irish operation will be the corporation’s centre of excellence in biopharmaceutical manufacturing and will be the launch-site for its strong late-stage biotech product pipeline.

Core Responsibilities

The appointee:

• Will serve as the site representative for the biotechnology operation with regard to all regulatory oversight and guidance
• Will oversee the preparation and documentation of specified regulatory submissions
• Will develop, plan and execute appropriate regulatory strategies and priorities through effective partnership with other departments such as scientific management (process and technology transfer), manufacturing, quality control and quality assurance
• Will keep up to date with, and as far as possible anticipate, new or changing regulatory requirements

Required Qualifications & Experience

Along with demonstrable expertise in regulatory affairs in a biotechnology environment:

• Ideally an advanced degree (MSc or PhD preferred) in related biological and life science field
• A minimum of 10 years’ post-qualification experience, with significant regulatory affairs expertise in a biotech setting
• Proven ability to build a technical organisation that delivers results and to effectively influence within and beyond the organisation

Candidates should contact John Glenny at MERC Partners on +353 (0)1 206-6700 for a confidential discussion or via email by clicking on the link below.

Click here to email John Glenny