FSP Regulatory Affairs Principle Specialist - Regulatory Liaison client dedicated

Work Schedule

Environmental Conditions

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.

SKILLS AND COMPETENCIES

• Regulatory Expertise: Strong knowledge of EU Clinical Trial Regulation (CTR) and global regulatory frameworks.
• Project Management:
  • Ability to manage complex tasks, prioritize effectively, and meet tight timelines.
  • Attention to detail.
  • Effectively and proactively collaborates per operating principles to drive assignments.
• Analytical Skills:
  • Ability to interpret regulatory guidelines and apply them to operational processes.
  • Problem-solving mindset: sound judgement and ability to analyse situations and information. Takes decisions based on facts and figures rather than on assumptions.
  • Can summarize content for focused/maintenance submissions.
• Technical Proficiency: Familiarity with regulatory submission systems and document management tools.
• Communication: Excellent written and verbal communication skills for cross-functional collaboration. Perfect command of English.
• Excellent interpersonal skills:
  • Able to work well and build relationships across a diverse set of stakeholders and characters.
  • Can train others on submissions.
• Resilience: Flexible mindset and resistant to stress and changes in strategy.

REQUIREMENTS:
• Master’s degree in a scientific discipline or equivalent through education and experience. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). Minimum 5 years’ experience in a similarly shaped Regulatory Liaison function.

• Preferred Fields of Study: Life Sciences, Chemistry, Biology, Pharmacy or related scientific field
• Professional certifications in Regulatory Affairs (RAC) beneficial
• Comprehensive knowledge of global regulations including FDA, EU MDR/IVDR, ICH guidelines
• Expert understanding of regulatory submission requirements
• Strong experience managing regulatory submissions and agency interactions
• Advanced project management and organizational skills
• Demonstrated leadership ability and experience managing regulatory teams and cross-functional teams.
• Strong written and verbal communication skills
• Excellent interpersonal skills for cross-functional collaboration
• Strong analytical and problem-solving capabilities
• Proficiency with regulatory submission tools and documentation systems
• Experience with quality management systems and GMP requirements
• Knowledge of clinical trial regulations and requirements
• Ability to interpret and implement new regulatory requirements
• Travel required 10-20%
• Fluency in English required; additional languages beneficial