Are you ready to take on a leadership role that impacts millions of lives worldwide? In this role, you will be at the forefront of managing teams within the Regulatory Affairs Sub-Function, focusing on the implementation and control of policy and strategy. While you will primarily handle short-term operational and tactical responsibilities, your contributions will be crucial in navigating the complexities of regulatory processes.
Your Key Responsibilities: As the Manager of Regulatory Affairs, you will:
Lead and Oversee:Guide the strategy implementation and operations for product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
Collaborate with Regulatory Agencies:Expedite approvals by interacting directly with regulatory bodies, ensuring clear and concise communication.
Serve as a Liaison:Act as the regulatory representative throughout the product lifecycle, working closely with marketing, research teams, and regulatory agencies.
Drive Product Approvals:Ensure timely approval of new drugs, biologics, or medical devices, and maintain continued approval of marketed products.
Advise Teams:Provide expert advice on manufacturing changes, line extensions, technical labeling, and regulatory compliance.
What We're Looking For: To thrive in this role, you should bring:
Manufacturing Expertise:Hands-on experience in manufacturing operations and managing manufacturing changes.
Leadership Skills:Proven experience in people management and resolving nonconformance issues.
Detail-Oriented Mindset:Strong attention to detail and excellent organizational skills.
Communication Skills:Ability to communicate effectively at all levels, particularly with EU and US regulatory bodies.
Qualifications and Experience: Educational Background:A minimum Level 8 Degree in Engineering, Science, or a related discipline.
Professional Experience:At least 5 years in a similar role with experience in EU regulatory bodies regarding applications and submissions, or equivalent international experience.
For a confidential discussion and more information on the role, please contactAisling Lane. ****** (021) 4320675
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