Director, Regulatory Affairs

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🕒 May 25

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Provide scientific interpretation of preclinical ophthalmology data including in vivo models to assess proof of concept • Translate nonclinical findings into regulatory and early clinical development recommendations • Define and guide the overall regulatory and clinical strategy for the program • Advise on optimal next steps in development including study design and development pathway • Support planning and execution of interactions with European regulatory authorities including scientific advice • Recommend appropriate regulatory pathways and authority engagement strategies within Europe

🎯 Requirements

• Bachelor’s degree in life sciences or equivalent, advanced degree preferred • Extensive experience in regulatory affairs with a focus on early phase strategy • Strong background in ophthalmology drug development • Proven experience interpreting preclinical data and linking it to clinical and regulatory strategy • Experience engaging with European regulatory authorities including scientific advice procedures

🏖️ Benefits

• Opportunities for personal and professional growth in a rewarding environment • Team values collaboration, quality, and making a difference in the lives of patients • Core values of Trust, Quality, Passion, Flexibility, and Sustainability