Global Regulatory Lead – Early Development

🔥 5 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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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 for assigned programs, focusing on first-in-human planning and early clinical development • Develop and communicate global regulatory strategies for early clinical programs, including regulatory approaches to initial clinical studies and key early development milestones • Advise teams on regulatory requirements and development plans, including how the nonclinical package supports first-in-human decisions • Represent the regulatory function on assigned project teams and relevant governance forums • Partner with scientists, clinicians, and cross-functional colleagues to coordinate regulatory activities and provide timely input • Contribute to regulatory documents and submissions, including INDs, CTAs, scientific advice requests, and other early development filings • Support high-quality interactions with health authorities, particularly the FDA and EMA, and help teams prepare for those interactions • Serve as a conduit between project teams, the client’s early development organization, and broader global regulatory and development teams • Monitor, interpret, and communicate changes in global regulations, guidelines, and health authority expectations • Support regulatory vendor oversight and ensure high-quality deliverables and health-authority interactions • Contribute to regulatory process and ways-of-working improvements • Support colleagues through mentoring and knowledge sharing

🎯 Requirements

• Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations • 5–7 years in global regulatory leadership roles focused on major regions such as the FDA, EMA, or PMDA • Thorough understanding of drug development • Strong global regulatory experience in early clinical development, including first-in-human planning and initial clinical studies • Ability to shape global regulatory strategies for early clinical programs and translate them into practical development plans • Ability to assess how the nonclinical package supports first-in-human decisions • Ability to coordinate regulatory documents and submissions supporting early clinical development, with a focus on the FDA • Experience interacting with regulatory and health authorities, especially the FDA and EMA • Knowledge of orphan drug development and the evolving regulatory landscape, particularly in the United States • Scientific curiosity and ability to engage credibly with scientists and clinicians on technical and business topics • Familiarity with current and emerging regulatory legislation, industry trends, and healthcare business practices globally • Strong organizational and project management skills, including strategic planning, prioritization, and coordination across multiple workstreams • Clear written and verbal communication skills, with ability to present complex regulatory topics and influence stakeholders effectively • Collaborative approach to building relationships and partnering across functions • Ability to work effectively in a fast-paced, results-driven, highly accountable environment • Pragmatic, creative, hands-on approach combining strategic thinking with independent and matrix-team execution • PhD or PharmD preferred

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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