Regulatory Affairs Principal Specialist – Regulatory Liaison

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Represent Regulatory Affairs at Clinical Trial Teams and cross-functional meetings • Serve as the main regulatory contact for clinical-trial matters between argenx and partners • Prepare, review, and coordinate regulatory submission packages, including CTAs, amendments, IBs, and IMPDs • Ensure timely and accurate submissions compliant with EU CTR and other regional requirements • Monitor delegated activities and oversee regulatory deliverables • Ensure adherence to global and local regulatory standards and company SOPs • Liaise with Transparency Leads/Liaisons regarding disclosure requirements • Maintain accurate documentation and tracking of regulatory activities • Contribute to process improvements and best practices within CTR Excellence • Collaborate with Regulatory Scientists, Regulatory Coordinators, and external partners to optimize workload • Guide strategic regulatory initiatives for medical devices, in-vitro diagnostics, and clinical research services • Interact with global health authorities and drive submission-quality excellence across jurisdictions

🎯 Requirements

• Master’s degree in a scientific discipline or equivalent through education and experience • 8+ years of comparable experience providing relevant knowledge, skills, and abilities • 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 certification in Regulatory Affairs (RAC) beneficial • Comprehensive knowledge of global regulations, including FDA, EU MDR/IVDR, and 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 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 • Willingness and ability to travel 10–20% • Fluency in English required; additional languages beneficial

🏖️ Benefits

• Fully remote work arrangement • Reasonable accommodation for individuals with disabilities • Other benefits and privileges of employment (details not specified)