Regulatory Affairs Manager – Regulatory Liaison

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

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

• Serve as the primary regulatory representative within assigned clinical trial teams • Coordinate and manage regulatory activities supporting global clinical development programs • Prepare, review, compile, and coordinate regulatory submission packages • Ensure submissions are completed accurately and within established timelines • Track regulatory milestones and submission status while maintaining oversight of regulatory deliverables • Maintain complete and inspection-ready regulatory documentation throughout the clinical trial lifecycle • Collaborate with Clinical Operations, Medical Affairs, Regulatory Strategy, Start-Up, Document Management, and other cross-functional teams

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related scientific discipline • Advanced degree (Master's or equivalent) preferred • Minimum 5 years of pharmaceutical, biotechnology, CRO, or clinical research experience • Minimum 3 years of experience in Regulatory Affairs supporting clinical trials • Experience preparing and coordinating global regulatory submissions • Experience working within cross-functional global project teams • Strong understanding of global clinical trial regulations • Knowledge of clinical trial start-up and lifecycle regulatory requirements • Strong organizational and planning skills • Ability to manage multiple studies and competing priorities • Excellent attention to detail • Ability to interpret complex regulatory requirements and translate them into operational activities • Experience with Electronic regulatory submission systems, CTMS, eTMF/EDMS, Microsoft Office Suite

🏖️ Benefits

• Continuous learning and career development opportunities • Inclusive, collaborative, and innovative culture