Global Regulatory Lead

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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

• Provide strategic, operational, and tactical regulatory insight on global pre-approval and post-approval activities • Guide the organization on filing strategy and coordinate across disciplines to ensure timely filings • Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high-quality interactions with regulators • Contribute hands-on to regulatory filings, including INDs, BLAs, MAAs, and other requested areas • Lead 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 for business decisions • Connect assigned project-team strategy with broader global regulatory and development teams • Build relationships and partner across the organization to achieve company goals • Lead, motivate, and develop a team in a matrix environment • Drive operational excellence and company culture in a fast-paced, results-driven environment

🎯 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 • PhD or PharmD preferred • Prior experience in rapidly growing pharmaceutical organizations desirable • Thorough understanding of the drug development process • Expertise in orphan drugs • Knowledge of evolving 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 • Affinity with science and ability to interact with scientists and clinicians • Ability to communicate with diverse individuals about technical and business topics • Familiarity with current and emerging regulatory legislation, industry trends, and global healthcare business practices • Highly developed organizational and project management skills • Demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization • Outstanding presentation, written, and verbal communication skills • Track record of successful interactions with regulatory and health authorities • Proven ability to build, motivate, and develop a team • Ability to combine strategic thinking with individual execution and team leadership in a matrix environment • Alignment with argenx values and readiness to drive company culture

🏖️ Benefits

• Reasonable accommodation for individuals with disabilities to participate in the job application or interview process, perform essential job functions, and receive employment benefits and privileges • Equal Opportunity Employer