Director of Regulatory Affairs, Dublin, Ireland
As part of an extensive project with an established client, we are now recruiting a Director of Regulatory Affairs on behalf of our client. This is a new role that will be based at the clients new central Dublin offices and will see the role holder manage a team of regulatory professionals based around the world.
Our client has an innovative product portfolio that has a well established presence in the majority of the world’s leading healthcare markets. The new Director of Regulatory Affairs will work with the senior management team and the board to bring new products to market as well as working with existing products.
The role holder will:
• Devise and enact a regulatory strategy for the company.
• Work with external consultants (Acorn Regulatory).
• Manage a team of regulatory specialists based in Dublin and a number of locations around the world.
• Develop and implement budgets, timelines and performance requirements.
• Develop regulatory strategies for domestic and international registrations and determine best regulatory path/action for device and drug products, both in development and post-approval.
• Manage development and post-approval registration.
•Represent company as liaison with regulatory agencies.
• Function as senior regulatory advisor on project teams when needed.
• Ensure regulatory documentation meets set standards and adheres to established regulatory strategy.
• Monitor progress of regulatory projects and responsibilities.
• Direct labeling function.
• Evaluate workload and resources relative to company and department goals.
The role would suit an individual with in excess of 5 years experience in the regulatory affairs sector. Applicants should have a minimum of a BSc.