Labeling Strategist – Regulatory Affairs AD

🔥 13 hours ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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

• Define and monitor authoring plans with the Global Regulatory Lead and Project Managers • Lead global labeling strategy with cross-functional US, EU, and Japan regulatory teams • Author target product labels, Company Core Data Sheets, core IFUs, US labels, prescribing information, patient information, and related documents • Lead and document labeling working groups and global labeling committees • Attend and contribute to Global Regulatory Team and submission teams • Review and contribute to label source documents, regulatory submissions, clinical documents, safety reports, and related materials • Develop global labeling implementation plans with Labeling Operations Managers • Supervise US mock-ups and Structured Product Labeling activities • Evaluate global and US labeling impact assessments and support database documentation • Assist with local dossier preparation and responses to Health Authority questions • Support publication of the labeling section of US eCTD dossiers • Serve as Global Labeling Committee Chairperson and provide oversight of committee requests • Act as global labeling expert in Safety Management Teams • Supervise labeling contributions to PSUR/PBRER, PSMF, US annual reports, and other regulatory procedures • Create, contribute to, and maintain labeling-related procedures • Participate in pharmacovigilance inspector or auditor interviews • Provide technical advice and review for regional and global regulatory submissions • Advise internal and external clients on regulatory strategy, legislation, and guidance • Ensure quality performance and compliance for managed projects • Manage project budgeting and forecasting and identify out-of-scope contract activities • Collaborate with business development on client presentations, proposals, pricing, and budgets • Oversee matrix/project leadership, training, and guidance for junior team members • Lead launch, review, project-team, and departmental initiative meetings

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • At least 5 years of experience in global labeling strategy • Previous experience in biologic products, medical devices, or combined products • Previous experience in clinical development and/or a global regulatory affairs environment • 12+ years of comparable knowledge, skills, and abilities to perform the job • Equivalent combination of appropriate education, training, and/or directly related experience may be considered • Deep knowledge of clinical development and end-to-end labeling processes • Knowledge of eCTD dossiers, labeling content, and labeling compliance management • Knowledge of regulatory, labeling, and clinical intelligence databases • Knowledge of Regulatory Information Management Systems and Electronic Document Management Systems such as Veeva Vault • Proficiency with Adobe Acrobat Pro, Microsoft Word, Excel, and PowerPoint • Mastery of English written and oral communication skills, as well as the local language where applicable • Exceptional attention to detail and editorial/proofreading skills • Advanced understanding of global, regional, and national regulatory requirements and procedures • Expert knowledge of ICH and other global regulatory guidelines • Advanced understanding of medical terminology, statistical concepts, and guidelines • Excellent budgeting and forecasting understanding • Professional negotiation, presentation, organizational, time-management, analytical, investigative, and problem-solving skills • Ability to work independently, exercise judgment, and manage multiple projects

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Occasional domestic and international travel