Global Regulatory Lead

🔥 16 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.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

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally • Guide filing strategy and coordinate across disciplines to ensure timely filings • Oversee regulatory affairs vendors involved in marketing authorization filings • Help ensure high-quality interactions with regulators • Contribute hands-on to regulatory filings, including INDs, BLAs, and MAAs • Provide regulatory leadership for post-approval activities, including drug registration and listing and payment of program user fees • Monitor, interpret, and communicate changes to the global regulatory landscape • Serve as regulatory affairs business partner to local commercialization teams • Partner with medical, legal, quality, PV, and distribution teams to provide timely regulatory input • Serve as conduit between assigned project-team strategy and broader global regulatory and development teams

🎯 Requirements

• Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations • At least 5–7 years in global leadership roles focused on major regulatory regions such as FDA, EMA, or PMDA • Thorough understanding of the drug development process • Expertise in orphan drugs • Knowledge of developing regulations and guidelines, specifically in the United States • Demonstrated ability to coordinate critical regulatory documents for medicine approvals, with a focus on the FDA • Experience interacting with regulatory authorities, especially the FDA and EMA • Familiarity with current and emerging regulatory legislation, industry trends, and global healthcare business practices • Highly developed organizational and project management skills • Strategic planning, delegation, resource allocation, and workload prioritization skills • Outstanding presentation, written, and verbal communication skills • Track record of successful interactions with regulatory and health authorities • Strong leadership ability, including building, motivating, and developing a team • Ability to operate in a fast-paced, results-driven, highly accountable environment • Ability to combine strategic thinking with individual and team execution in a matrix environment • PhD or PharmD preferred • Prior experience in rapidly growing pharmaceutical organizations desirable

🏖️ Benefits

• Fully Remote work mode • Standard Monday–Friday work schedule

📊 Check your resume score for this job

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

Upload Resume