Director Regulatory Affairs - Freelance

Job description

About this role TFS HealthScience is a leading global mid size Contract Research Organization CRO that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service FSP solutions. The Regulatory Strategy Consultant Ophthalmology is responsible for providing expert scientific and regulatory guidance on an early phase drug reformulation project, including interpretation of preclinical data and defining the optimal regulatory and clinical development strategy in Europe. As part of our SRS FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area. This is contract position at 0.2FTE Key Responsibilities: - 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 desi...