FSP Regulatory Affairs Principle Specialist - Regulatory Liaison client dedicated

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our collaborative team at Thermo Fisher Scientific as a Regulatory Affairs Manager, where you'll make a meaningful impact on global healthcare. You'll guide strategic regulatory initiatives for our innovative medical devices, in-vitro diagnostics, and clinical research services. Working closely with cross-functional teams, you'll ensure regulatory compliance while supporting product development and market access. This role offers the opportunity to shape regulatory strategy, interact with global health authorities, and drive excellence in submission quality across multiple jurisdictions.

PURPOSE OF THE FUNCTION

The Regulatory Liaison acts as the primary regulatory interface for clinical trial teams, ensuring compliance with global and local regulations, facilitating timely submissions, and maintaining transparency throughout the trial lifecycle. This role bridges regulatory strategy and operational execution, supporting CTR Excellence objectives

ROLES AND RESPONSIBILITIES

• Represent Regulatory Affairs at Clinical Trial Teams (CTTs) and cross-functional meetings.
• Serve as the main point of contact for clinical trials regulatory matters between argenx and partners.
• Prepare, review, and coordinate regulatory submission packages (CTAs, amendments, IBs, IMPDs) with partners.
• Ensure timely and accurate submissions in compliance with EU CTR, and other regional requirements.
• Monitor delegated activities and maintain oversight of regulatory deliverables.
• Ensure adherence to global and local regulatory standards and company SOPs.
• Liaise with Transparency Lead/Liaisons to ensure compliance with disclosure requirements.
• Maintain accurate documentation and tracking of regulatory activities.
• Contribute to process improvements and best practices within CTR Excellence.
• Collaborate closely with Regulatory Scientists, Regulatory Coordinators and External Partners to optimize workload.