Regulatory Affairs Manager Job In Kilkenny

Job Description

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:

1. Lead and Oversee: Guide the strategy implementation and operations for product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
2. Collaborate with Regulatory Agencies: Expedite approvals by interacting directly with regulatory bodies, ensuring clear and concise communication.
3. Serve as a Liaison: Act as the regulatory representative throughout the product lifecycle, working closely with marketing, research teams, and regulatory agencies.
4. Drive Product Approvals: Ensure timely approval of new drugs, biologics, or medical devices, and maintain continued approval of marketed products.
5. 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:

1. Manufacturing Expertise: Hands-on experience in manufacturing operations and managing manufacturing changes.
2. Leadership Skills: Proven experience in people management and resolving nonconformance issues.
3. Detail-Oriented Mindset: Strong attention to detail and excellent organizational skills.
4. Communication Skills: Ability to communicate effectively at all levels, particularly with EU and US regulatory bodies.

Qualifications and Experience:

1. Educational Background: A minimum Level 8 Degree in Engineering, Science, or a related discipline.
2. Professional Experience: At least 5 years in a similar role with experience in EU regulatory bodies regarding applications and submissions, or equivalent international experience.