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Regulatory Affairs Manager

  • Sector: Science & Pharma
  • Contact Email: aisling.lane@collinsmcnicholas.ie
  • Job Ref: 23042

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 contact Aisling Lane.

aisling.lane@collinsmcnicholas.ie

(021) 4320675